Stem Cell Clinic

Cell Culture Market Size to Exceed US $42 Billion by 2026 – Post Register

SELBYVILLE, Del. - November 25, 2019 - ( Newswire.com )

As per the latest research report titled " Cell Culture Market Share, Size, Trends & Industry Analysis Report By Consumables (Media, Sera, Reagents); By Product (Pipetting Instruments, Centrifuges, Biosafety Instruments, Culture Systems, Incubators, Cryostorage Equipment); By Application and By Regions: Segment Forecast, 2019 2026"available with Market Study Report LLC, the global cell culture market is anticipated to grow with a CAGR of 11.8% through the year 2026.

Cell culture is effectively applied in evaluation and treatment of diseases such as cancer and Alzheimers. Increasing adoption of techniques to develop high-quality plant actives, coupled with rising focus of key players towards widening their cell reservoir and recruiting trained experts for enhanced efficiency are propelling the growth of the cell culture market.

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Moreover, increasing demand for cell culture is unable to be met by conventional development and manual handling, which is compelling the incorporation of automated techniques that offer higher purity and larger quantity. Constant advancements in techniques, along with discovery of new functions of cell cultures will further augment the expansion of the cell culture market.

Based on product type, the cell culture market is classified into pipetting instruments, biosafety instruments, incubators, centrifuges, culture systems, and cryostorage equipment. As per application spectrum, the industry is divided into tissue culture & engineering, drug development, vaccine production, biopharmaceuticals, gene therapy, and toxicity testing.

In terms of consumables, the cell culture market is categorized as media, reagents, and sera. The report cites that thesera segment held 45% revenue share of the cell culture market in 2018, owing to surging commercialization of the segment and the high price of the product.

Considering the regional landscape, the Asia Pacific cell culture market is presumed to gain lucrative growth opportunities over the forecast period, on account of surging need for advancements and manufacturing of medications, vaccinations, and biologics. Supportive federal reforms, inflow of funding from market players, and untouched potential of market will further drive the regional market growth.

Main contenders of the global cell culture market profiled in the report are Sartorius, Thermo Fisher Scientific, Sigma-Aldrich Co., General Electric, Eppendorf, Merck, Becton, Promocell, Lonza, and Dickinson & Company.

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Question & Answer: Cell Culture Market

Question 1: Why is the cell culture market registering constant growth?

Answer: Cell culture is effectively applied in evaluation and treatment of diseases such as cancer and Alzheimers. Increasing adoption of techniques to develop high-quality plant actives, coupled with rising focus of key players towards widening their cell reservoir and recruiting trained experts for enhanced efficiency are propelling growth of the cell culture market.

Question 2: Which segment held a significant share of the cell culture market in 2018?

Answer: In terms of consumables, cell culture market is categorized as media, reagents, and sera. The report cites that thesera segment held 45% revenue share of the cell culture market in 2018, owing to surging commercialization of the segment and the high price of the product.

Question 3: How is the Asia Pacific region impacting the growth of cell culture market?

Answer: Asia Pacific cell culture market is presumed to gain lucrative growth opportunities over the forecast period, on account of the surging need for advancements and manufacturing of medications, vaccinations, and biologics. Supportive federal reforms, inflow of funding from market players, and untouched potential of the market will further drive the regional market growth.

Question 4: What companies define the competitive landscape of cell culture market?

Answer: Main contenders of the global cell culture market profiled in the report are Sartorius, Thermo Fisher Scientific, Sigma-Aldrich Co., General Electric, Eppendorf, Merck, Becton, Promocell, Lonza, and Dickinson & Company.

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Stem Cell Therapy Market Size By Type, By Application, End-users Forecast, 2019 - 2025

Stem Cell Therapy Market will exceed USD 15 billion by 2025, as per a new research report.

Increasing research on developing novel therapies and personalized medicines will foster stem cell therapy market growth. For instance, scientists are extensively researching methods to regenerate healthy heart cells from placenta that can be used in patients after myocardial infarction. This discovery will help to cure patients suffering from cardiovascular diseases and reduce mortality rates. Researchers are further examining different aspects of stem cell therapy for its applications in neurological disorders. Thus, increasing R&D activities to promote developments in stem cell therapy will positively impact industry growth.

A rising geriatric population will positively influence the industry growth in coming years. Elderly people are susceptible to degenerative diseases such as Parkinson's and Alzheimer's disorders. Stem cell therapies offer several benefits over the conventional therapeutic methods that raise its preference for curing degenerative diseases. Recently developed stem cell therapies generate healthy cells by replacing the defective cells through minimally invasive techniques. Therefore, the geriatric population relies on stem cell therapies that provebeneficial for industry growth.

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Related Links Stem Cell Therapy Market will exceed USD 15 billion by 2025Cell Banking Outsourcing Market 2019-2025

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Cell Culture Market Size to Exceed US $42 Billion by 2026 - Post Register

AVITA Medical Teams With Gates Center to Advance Therapeutic Skin Restoration – CU Anschutz Today

AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, and scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine have announced a preclinical research collaboration to establish proof-of-concept and explore further development of a spray-on treatment of genetically modified cells for patients with epidermolysis bullosa (EB), with potential applicability to other genetic skin disorders.

The partnership will pair AVITA Medicals patented and proprietary Spray-On Skin Cells technology and expertise with the Gates Centers innovative, patent pending combined reprogramming and gene editing technology to allow cells to function properly. Under the terms of the Sponsored Research Agreement (SRA), AVITA Medical retains the option to exclusively license technologies emerging from the partnership for further development and commercialization. The Gates Center team is further supported by the EB Research Partnership in New York, the Los Angeles-based EB Medical Research Foundation, the London-based Cure EB Charity and government grants, in a collaborative effort to rapidly develop and translate this technology to the clinic for meaningful impact on patient lives.

The Gates Center is a leader in developing therapeutic approaches for genetic skin diseases. Researchers at the Gates Center have developed a powerful new approach for treating genetic skin disorders and improving the lives of patients with epidermolysis bullosa, said Mike Perry, PhD, chief executive officer of AVITA Medical and adjunct professor at the Gates Center for Regenerative Medicine. We look forward to collaborating with the team at the Gates Center on the expanded use of our technology. This agreement marks an important milestone in AVITAs mission to harness the potential of regenerative medicine to address unmet medical needs across a broad range of dermatological indications, including genetic disorders of the skin.

Epidermolysis bullosa is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins resulting in skin fragility and blistering, leading to chronic wounds and, in some sub-types, an increased risk of squamous cell carcinoma or death. There are no approved curative therapies, and current treatment is palliative - focused primarily on pain and nutritional management, itching relief, wound care, and bandaging.

Its very exciting to partner with AVITA Medical to help advance our epidermolysis bullosa program, said Director of the Gates Center for Regenerative Medicine Dennis Roop, PhD. Were looking forward to exploring a novel approach to delivering gene-edited skin cells to patients that addresses current treatment challenges.

We believe that Spray-On Skin Cells technology combined with our genetically corrected cells has the potential to be game changing in the treatment of this disease. This combination could reduce time to treatment, lower manufacturing complexity, reduce costs and improve patient outcomes, said Ganna Bilousova, PhD, assistant professor of dermatology, who is a co-principal investigator on this research program.

ABOUT THE CHARLES C. GATES CENTER FOR REGENERATIVE MEDICINE

The Charles C. Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist, Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world. The Gates Center aspires to honor what he envisionedby doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.

Led by Founding Director Dennis Roop, PhD, the Gates Center is located at the University of Colorados Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Childrens Hospital Colorado and the Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.

ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE

Faculty at the University of Colorado School of Medicine work to advance science and improve care. These faculty members include physicians, educators and scientists at University of Colorado Hospital, Childrens Hospital Colorado, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. The school is located on the CU Anschutz Medical Campus, one of four campuses in the University of Colorado system. To learn more about the medical schools care, education, research and community engagement, visit its web site.

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. Burn Centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

Photo at top: From left, Igor Kogut, PhD, Ganna Bilousova, PhD, and Dennis Roop, PhD.

Guest contributor: Gates Center for Regenerative Medicine/ASX

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AVITA Medical Teams With Gates Center to Advance Therapeutic Skin Restoration - CU Anschutz Today

Star Trek’s William Shatner Receives Stem Cell Treatment to Restore his Youth – Magazine of Santa Clarita

The 88-year-old actor known for his role as Captian James T. Kirk on the popular cinema and television series Star Trek, William Shatner recently Tweeted, Today I received restorative stem cells and told his followers Is it possible to turn back the clock? I will let you know.Mr. Shatner also tweeted the Stem Cells are manufactured by Invitrx.Center for Regenerative Medicine & Stem Cell Therapy at Valencia Medical Center is a pioneer in stem cell regenerative medicine in Santa Clarita Valley has been producing PRP and stem cell treatments for cosmetic treatments for cosmetic rejuvenation, hair restoration and chronic knee pain due to arthritis knee meniscus injury, cartilage, ligaments (ACL, MCL), osteoarthritis treatment. Invitrx, a California native is a global research-based company in regenerative medicine and is a major source of stem cell products for Valencia Medical Center.Non-surgical regenerative cell-based treatment uses the bodys natural healing ability to repair damaged bones, muscles, cartilage, tendons and ligaments. Knee injuries are painful and often patients are unable to walk. Our treatment protocol always uses products following FDA guidelines. Injections done with ultrasound guided needle recognition capability to ensure safety as well target the area needing treatment. Plasma; Alpha-2-Macroglobulim (A2M) is the new biologic treatment for your arthritic knee (osteoarthritis)When your hips hurt, or your knee is stiff, or your back is throbbing, that means your joint is bone on bone and there is no lubrication to ease movement.Regenerative medicine giving new hope to patients suffering from painful joint injuries such as knee, shoulder and hip with a chance to live a pain free life.Regenerative cell-based ultrasound guided injection now available to treat pain associated with joint injury. There are indications that it reduces the pain and swelling of the joints and helps lubricating and improve movements.Commonly Treated Conditions: Osteoarthritis of the Hips, Knee, and Shoulders Rotator Cuff tears of the Shoulder Meniscus, ACL and PCL tears of the kneeOur stem cell treatment using your own stem cells and with using imaging guidance ensures precise injection of stem cell, it is a highly-specialized practice.Besides treating above injuries we have advance stem cell micro-needling treatment for the following: Cell-based PRP Hair Restoration combining micro-needling with growth factors and hair follicles voluma vitamins plus BLotinyl T1, Biotin, Anti-aging and Kopexil. Non-toxin facial renewal Anti-Aging APGF Advanced Peptide Micro-needling PRP, Dual Anti-Aging Ampoules for deep hydration, more collagen to reduce wrinkles and firm skin.Dr. Ibrahim is the staff physician at Valencia Medical Center specializing in regenerative medicine, pain management, and rejuvenation. Call for a consultation at 661-222-9117.

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Star Trek's William Shatner Receives Stem Cell Treatment to Restore his Youth - Magazine of Santa Clarita

Outpatient ASCT for Myeloma Found Safe, Effective With Proper Patient Selection – Cancer Therapy Advisor

Administering high-dose chemotherapy and autologous stem cell transplant (ASCT) in an outpatient setting was safe and feasible for patients with multiple myeloma, according to the results of a single-center study.

Researchers at Vancouver General Hospital, which has the sole hematopoietic transplant program in British Columbia, Canada, have been conducting outpatient ASCT for patients with plasma cell disorders since 2004.

Patients with poorer performance status and cardiac amyloidosis are followed more closely and have a lower threshold for hospital admission, they noted.

They conducted a retrospective study of these procedures performed from 2007 to 2016 to analyze safety and outcomes. During this time, 724 patients underwent 752 ASCTs. The median age of patients was 60. The majority of patients underwent conditioning with melphalan 200 mg/m2.

Patients were recommended for transplant for myeloma (96.9%), amyloidosis (2.4%), and POEMS syndrome (0.7%). Median time from diagnosis to transplant was 5 months.

Approximately one-third of patients required admission to the inpatient ward within the first 30 days after transplant. The median time to this admission was 9 days, and patients were in the inpatient ward for a median of 6 days. The most common causes of hospitalization were febrile neutropenia and mucositis.

However, the overall transplant-related mortality was low at 0.4%. The day 100 all-cause mortality was also low at 0.9%.

Outpatient ASCTs are safe and result in decreased resource utilization, the researchers wrote. Patient selection, appropriate prophylactic antibiotic regimen, a well-equipped and staffed daycare unit to treat infectious complications and administer transfusion blood products, and a multidisciplinary team is essential to deliver this model of care.

Reference

Kodad SG, Sutherland H, Limvorapitak W, et al. Outpatient autologous stem cell transplants for multiple myeloma: analysis of safety and outcomes in a tertiary care center [published online October 8, 2019]. Clin Lymphoma Myeloma Leuk. doi: 10.1016/j.clml.2019.09.619

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Outpatient ASCT for Myeloma Found Safe, Effective With Proper Patient Selection - Cancer Therapy Advisor

Cell Isolation Market To Reach USD 18.26 Billion By 2026 | Reports And Data – GlobeNewswire

New York, Nov. 25, 2019 (GLOBE NEWSWIRE) -- In the recent years, interest of biotechnology companies and scientists in cancer and stem cell research has increased. Advanced cell isolation products deliver improved separation of biological molecules including proteins, nucleic acids, chromatin and protein complexes for further analysis. In addition to this, there has been an increase in demand for personalized medicine. This has further helped this market grow.

According to the current analysis of Reports and Data, The global cell isolation market was valued at USD 4.9 billion in 2018 and is expected to reach USD 18.28 billion by the year 2026, at a CAGR of 17.7%. Cell isolation is the process of extracting a specialized cell from a heterogeneous mixture and then process it to identify its properties and replicate it to develop new therapies. For the determination of appropriate separation technique, an exhaustive analysis of the cell size, cell behavior, density, antigen status, and hydrophobic surface properties are done.

Cell isolation plays a very vital role in the diagnostics and research of chronic diseases. It helps in drug discovery by studying the behaviour of the cells and their response to disease and drugs. This technique of drug discovery helps to generate medicines that can be used for the treatment of various diseases such as cancer, genetic disorders, and autoimmune diseases. With incidents of chronic diseases on the rise across the world, the research, drug development, and clinical trials on various cell-based therapies also need to be increased. Therefore, the demand for cell isolation market will also have a boost.

This will be a significant factor fuelling the growth of the cell isolation market. The cell separation techniques play a vital role in personalized medicines, which are used for early detection of disease, selection of appropriate treatment, and determining the prognosis of the therapy. All these factors have contributed towards a positive dynamic growth curve of this market, and it is expected to keep growing in the coming years.

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Further key findings from the report suggest:

To identify the key trends in the industry, click on the link below: https://www.reportsanddata.com/report-detail/cell-isolation-market

Segments covered in the report:

For the purpose of this study, Reports and Data have segmented the cell isolation market on the basis of product, cell type, technique, application, end use and region:

Product (Revenue in USD Billion, 2018 - 2026)

Consumables

Reagents, kits, media, and sera

Beads

Disposables

Instruments

Centrifuges

Flow cytometers

Filtration systems

Magnetic-activated cell separator systems

Delivery Mode Type (Revenue, USD Million; 20162026)

Human cells

Differentiated Cells

Stem Cells

Animal Cells

Technique (Revenue in USD Billion, 2018 - 2026)

Application (Revenue in USD Billion, 2018 - 2026)

End Use (Revenue in USD Billion, 2018 - 2026)

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Regional Outlook (Revenue in USD Million; 20162026)

North America

o U.S.

o Canada

Europe

o Germany

o France

o UK

o Spain

o Italy

o Rest of the Europe

Asia Pacific

o China

o India

o Japan

o Rest of Asia-Pacific

Middle East & Africa

o Latin America

Brazil

About Reports and Data

Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target and analyze consumer behavior shifts across demographics, across industries and help clients make a smarter business decision. We offer market intelligence studies ensuring relevant and fact-based research across a multiple industries including Healthcare, Technology, Chemicals, Power, and Energy. We consistently update our research offerings to ensure our clients are aware about the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise.

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Cell Isolation Market To Reach USD 18.26 Billion By 2026 | Reports And Data - GlobeNewswire

Seattle Genetics Announces Health Canada Approval of ADCETRIS (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing…

BOTHELL, Wash.--(BUSINESS WIRE)--

- Approval of Supplemental New Drug Submission for ADCETRIS in Combination with CHP Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma based on Positive Phase 3 ECHELON-2 Clinical Trial Results -

Seattle Genetics, Inc. (SGEN) today announced that Health Canada has approved the supplemental New Drug Submission that expands the use of ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) chemotherapy for the treatment of previously untreated adult patients with systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumours express CD30. The approval is based on positive results of the phase 3 ECHELON-2 clinical trial that compared ADCETRIS plus CHP to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). Health Canada granted a Priority Review Designation for this submission. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL.

The Health Canada approval of ADCETRIS (brentuximab vedotin) in combination with CHP chemotherapy in newly diagnosed CD30-expressing peripheral T-cell lymphoma represents the first major advance for Canadian patients with PTCL in decades, said Kerry Savage, M.D., Medical Oncologist at the BC Cancer Agency, Professor of Medicine at the University of British Columbia and investigator on the ECHELON-2 clinical trial. The approval is based on the ECHELON-2 clinical trial that demonstrated ADCETRIS (brentuximab vedotin) plus CHP regimen was superior for both progression-free survival and all key secondary endpoints, including overall survival, when compared to the standard of care CHOP chemotherapy.

The current standard of care for initial treatment of peripheral T-cell lymphoma is multi-agent chemotherapy, which results in low complete remission rates and poor progression-free and overall survival. ECHELON-2 is the first randomized trial to demonstrate an overall survival benefit over established standard therapy, making it a meaningful advance in the treatment of these rare lymphomas, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. With this new indication for ADCETRIS, physicians and eligible patients in Canada now have access to this important new regimen for treating frontline CD30-expressing peripheral T-cell lymphoma, another milestone supporting our plans to continue to expand ADCETRIS globally to patients in need.

In May 2019, Health Canada approved the supplemental New Drug Submission that expanded the use of ADCETRIS in combination with AVD (Adriamycin, vinblastine and dacarbazine) chemotherapy in patients with previously untreated Stage IV Hodgkin lymphoma (HL) based on the results of the phase 3 ECHELON-1 clinical trial.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Story continues

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About Seattle Genetics

Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) utilizes the companys industry-leading antibody-drug conjugate (ADC) technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has a late-stage pipeline including enfortumab vedotin for metastatic urothelial cancer, currently being reviewed for approval by the FDA, and tisotumab vedotin in clinical trials for metastatic cervical cancer, which utilize our proprietary ADC technology. In addition, tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer and in clinical development for metastatic colorectal cancer. We are also leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Most Common (20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here.

Forward-Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential utilization of ADCETRIS (brentuximab vedotin) for previously untreated adult patients with systemic anaplastic large cell lymphoma, peripheral T-cell lymphoma-not otherwise specified or angioimmunoblastic T-cell lymphoma, whose tumours express CD30 in Canada and the therapeutic potential of ADCETRIS in this indication. Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to factors such as utilization and adoption of the approved treatment regimen by prescribing physicians, competitive conditions including the availability of alternative treatment regimens, the availability and extent of reimbursement, the risk of adverse events, and adverse regulatory action. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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Seattle Genetics Announces Health Canada Approval of ADCETRIS (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing...