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US FDA Approves Kite’s Tecartus as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia | DNA RNA and…

Details Category: DNA RNA and Cells Published on Monday, 04 October 2021 20:29 Hits: 291

-- 65% of Patients Achieved Overall Complete Remission with Tecartus --

-- High Unmet Need: Fifty Percent of Adult Patients Will Relapse on Currently Available Treatments --

-- Approval Marks Kites Fourth Indication for its Cell Therapies and First in Leukemia --

SANTA MONICA, CA, USA I October 01, 2021 I Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Following FDA Breakthrough Therapy Designation and a priority review, Tecartus is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (18 years and older) with ALL. There is a high unmet need, as half of this patient population will relapse, and median overall survival (OS) is only approximately eight months with current standard-of-care treatments. Patients can access Tecartus through 109 authorized treatment centers across the U.S.

Adults with ALL face a significantly poorer prognosis compared to children, and roughly half of all adults with B-ALL will relapse on currently available therapies, said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. We now have a new meaningful advancement in treatment for these patients. A single infusion of Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.

The approval is based on results from ZUMA-3, a global, multicenter, single-arm, open-label study in which 65% of the evaluable patients (n=54) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) at a median actual follow-up of 12.3 months. The duration of CR was estimated to exceed 12 months for more than half the patients. Among efficacy-evaluable patients, median duration of remission (DOR) was 13.6 months. Among the patients treated with Tecartus at the target dose (n=78), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 26% and 35% of patients, respectively, and were generally well-managed.

Today marks Kites fourth FDA approved indication in cell therapy in under four years, demonstrating our commitment to advancing CAR T for patients across many different hematologic malignancies, said Christi Shaw, Chief Executive Officer of Kite. Tecartus has already transformed outcomes for adults living with mantle cell lymphoma, and we look forward to offering the hope for a cure to patients with ALL.

Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant. CAR T-cell therapy works differently, by harnessing a patients own immune system to fight cancer. With CAR T, the patients blood is drawn and the T cells are separated. Then the T cells are genetically engineered with a specific receptor that enables them to identify and attack cancer cells, and put back into the patients body.

Roughly half of all ALL cases actually occur in adults, and unlike pediatric ALL, adult ALL has historically had a poor prognosis, said Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS). Developing new therapies that would be life-changing for people with cancer has been a dream of LLS. We are proud to see the potential of CAR T realized for even more people with this approval for brexucabtagene autoleucel.

Tecartus is also currently under review in the European Union and United Kingdom for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.

The Tecartus U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Tecartus is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

Additional Information About ZUMA-3 Trial

Further efficacy results from the ZUMA-3 trial have been published and presented in scientific forums. Published Phase 1 data showed 32% of responders (n=22) were still in remission at the median follow-up of 22.1 months. In Phase 2 data presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, investigators reported that among treated patients (n=54), 31% of these patients were in ongoing response at a median follow-up of 16.4 months. 97% of responders had deep molecular remission, with undetectable minimal residual disease (MRD), and median OS among all responders has not yet been reached. A safety analysis, reported in the Lancet, showed among all patients who experienced a neurologic event, 94% of CRS events and 88% of neurologic events were resolved.

ZUMA-3 is an international multicenter, registrational Phase 1/2 study in adult patients (18 years old) with ALL whose disease is refractory to or has relapsed following first standard systemic therapy with remission of 12 months or less, after two or more lines of systemic therapy or at least 100 days after allogeneic stem cell transplantation. Seventy-one patients were enrolled (and leukapheresed) in the study, and the primary endpoint was overall complete remission rate (OCR, equaling complete remission plus complete remission with incomplete hematologic recovery) as determined by an independent review.

About ALL

ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. Approximately 1,000 adults are treated annually for relapsed or refractory ALL. B-cell precursor ALL is the most common form, accounting for approximately 75% of cases, and treatment is typically associated with inferior outcomes compared with other types of ALL. Survival rates remain very poor in adult patients with relapsed or refractory ALL, with median OS at less than eight months.

About Tecartus

Tecartus is an autologous, anti-CD19 CAR T-cell therapy. Tecartus uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. Tecartus is also being evaluated in pediatric ALL, where its use is investigational, and its safety and efficacy have not been established.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Tecartus Indication

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

SOURCE: Kite Pharma

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US FDA Approves Kite's Tecartus as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia | DNA RNA and...

Lack of awareness about blood stem cell donation is one of the leading causes for low number of donors in In.. – ETHealthworld.com

Shahid Akhter, editor, ETHealthworld spoke to Dr. Dinesh Bhurani, Director, Department of Hemato-Oncology & Bone Marrow Transplant, Rajiv Gandhi Cancer Institute and Research Centre, to know about the progress of NPRD and the challenges associated with blood stem cell transplants.

How do you think the National Policy for Rare Diseases will impact the treatment of patients suffering from rare blood disorders? Will it help reduce the lag that we often see in policy and practice when it comes to healthcare systems? National Policy on Rare Diseases is a step-in right direction and must be welcomed by the Indian medical fraternity. It not only recognizes rare diseases for the first time in India but also has brought forward the possibility of affordable treatment for life-threatening rare diseases which were not previously covered under the national health program. The policy advocates access for treatment through center of excellences, crowd funding and financial assistance.

The NPRD in a bid to enable patients suffering from rare blood disorders has laid emphasis on the option of one-time curative treatment through hematopoietic stem cell transplant for diseases such as Severe Combined Immunodeficiency (SCID), Chronic Granulomatous disease, Wiskott Aldrich Syndrome, Osteopetrosis, and Fanconi Anaemia. By committing to provide a Rs. 20 lakhs cover for the one-time treatment cost of diseases falling under Group 1 through the umbrella scheme of Rashtriya Arogya Nidhi, the NPRD has attempted to provide coverage to almost 40 per cent of the population who are eligible under the Pradhan Mantri Jan Arogya Yojana. The NPRD as a policy that advocates affordable and accessible healthcare and has the potential to lead to the creation of a conducive healthcare ecosystem whereby multisectoral partnerships can collaboratively work towards reduction in the lag between policy and practice often seen otherwise, thereby leading people to live healthier and fuller lives.

Another reason for low number of donors in India is the misconception that stem cell donation comes with a cost to donor. This idea is completely misplaced and untrue as the cost of procedure starting from sample collection, donation and travel is free of cost, and covered under the cost of treatment of a patient for whom the donation is needed. Added to this is the fact that the number of organizations working in the country in the space of blood stem cell transplant is limited at best, thus awareness generation as compared to other health issues is nominal. However, the situation is gradually evolving and ICMR in its 2021 guidelines has gone on to recognize seven registries across the country as active stakeholders in this ecosystem. This recognition by ICMR will hopefully lead to greater awareness generation.

For blood stem cell transplant knowledge is key in establishing patient donor linkage, and by storing the requisite information with them, these registries do just that. Technology is a tool that has been successfully leveraged by stakeholders in the ecosystem to establish linkages. The Hap- E Search is one such tool that has been used by hospitals in the country to find donor matches for their patients. This software is perhaps one of the most enabling tools available to us in the ecosystem, as it helps find HLA matches not just in the country but across the world. This software is now being used by many government hospitals like AIIMS, Delhi and PGIMER Chandigarh. Once the matching donor is found via the HAP-E Search, the donor is encouraged to make the donation, provided counselling and support to donate blood stem cells, and post donation the stem cells are transported to the patients location.

The NPRD proposed crowdfunding and PPP models to ensure more patients availing treatment for rare diseases. How beneficial do you think such partnerships can be to enable blood stem cell transplant ecosystem? Treatment for rare diseases has been found to be expensive across the world. It is thus that despite stem cell transplants being a proven effective solution in the case of some blood disorders, affordability continues to be a challenge for patients and their families. With treatment costs ranging anywhere between Rs. 15-45 lakh, it remains out of reach for most patients in the country. Also, blood disorders, classified as rare, have limited infrastructure in health systems, networks, and subsidies for patients to access treatments are few. In such a scenario, crowdfunding is definitely a feasible option for patients that would ensure that they do not have to forego treatment due to a paucity of resources.

As per the NPRD, the money raised through crowdfunding would directly get credited to the treatment centre thus ensuring that there is adequate linkage. Further, the public private partnership model suggested by the government has enabled it to avail the support of non- governmental and not-for- profit agencies present in the country. This is truly commendable as not only will this ensure more patient donor linkage in the blood stem transplant ecosystem but will also lead to greater awareness generation and registrations of donors as well. One significant organization that has already partnered with the government in this arena is the DKMS BMST Foundation India. With over 50,000 blood stem cell donors registered with them, this organization has been steadily working towards enabling the ecosystem. In the case of rare diseases, it is imperative that stakeholders do not work in isolation and the government working alongside the private can lead to greater hope for many patients with greater amenities and facilities for treatment being made accessible to them.

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Lack of awareness about blood stem cell donation is one of the leading causes for low number of donors in In.. - ETHealthworld.com

‘Survivor’ winner Ethan Zohn opens up about his cancer battle: I was a healthy, young guy. You never expect it to be you. – Yahoo Life

Ethan Zohn details his cancer battle to Yahoo Life. (Photo: Ethan Zohn)

Ethan Zohn is a survivor in more ways than one. The former professional soccer player rose to fame after taking home the ultimate prize on Survivor: Africa in 2001, going on to compete on the long-running reality show twice more, as well as on programs like The Amazing Race and Fear Factor. It was in 2009, however, that he faced his most personal challenge yet: a lymphoma diagnosis.

Now, Zohn who used some of his Survivor prize money to co-found Grassroot Soccer, an organization in support of HIV-AIDS prevention in Africa is an ambassador for the Lymphoma Research Foundation, the nations largest non-profit organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma community with education programs, outreach initiatives and support services. Thus far, LRF has raised more than $67 million for the cause, which is close to Zohns heart he credits lymphoma research with saving his life following the failure of several cancer treatments.

The reality star, who returned to Survivor last year for its 20th anniversary Winners at War season, spoke to Yahoo Life about what hes learned from beating cancer and how Survivor changed the trajectory of his life.

What would you tell yourself looking back on your reality TV experience?

I would probably tell myself, "Dude, dont take everything so seriously." The whole reason I tried out for Survivor was because of a series of epic failures in my life. I was cut from my soccer team, I was unemployed, I got an advertising job in New York I was fired from. I told my mom, "Everything is okay, Ill get a job, Im just between life choices." I signed up for Survivor on a whim, and I got on. Back then, I was just a dude looking for an adventure, so when Survivor ended it was so crazy I was in the public eye, giving speeches and appearances, and it just got so overwhelming. I thought everything meant so much. Every single thing I said in a magazine. But fast forward a bunch of years, and cancer hit, and all that little stuff means nothing in the grand scheme of things. With cancer, things got pretty clear pretty quickly, so I wish I didnt spend so much time stressing out about every little thing how my hair looked. Stuff like that.

Story continues

Ethan Zohn, a three-time Survivor contestant, details his cancer battle to Yahoo Life. (Photo: Ethan Zohn)

What was your cancer diagnosis experience?

In 2008, I was working with Grassroot Soccer, which is the charity that I started using the money from Survivor to start. I did this big campaign where I dribbled a soccer ball from Boston to Washington, D.C. I started getting really itchy skin, and I tried every pill, cream and lotion known to man but it didnt help. Eventually, I was diagnosed with CD20-positive Hodgkin's lymphoma. The shock of getting that diagnosis was magnified as the only connection I had to cancer was through my dad. When I was 14, cancer came and took my dad away from me. Cancer, to me, equaled death, so when I was diagnosed, I was petrified. I was 35, I was training for the New York City Marathon. I was a healthy, young guy. You never expect it to be you. When all my friends were starting their life, I had to press pause on mine.

I went through multiple rounds of chemotherapy, 22 blasts of radiation, stem cell therapy, which worked for a little while but 20 months later the cancer returned. Getting the news that the cancer had returned was deflating, because I had already had treatment and I was running out of options. Fortunately, at that exact moment in time, just when I needed it most, there was a new targeted therapy. I was then able to then get another stem cell treatment, using my brother as a donor.

Now, Im heavily involved with the Lymphoma Research Foundation. They do an incredible amount of work for cancer research, especially blood cancer research. Personally, I wouldnt be alive if it werent for cancer research, and for organizations like the LRF. I often think to myself, How cool is it that there are complete strangers running marathons, selling cookies, donating money for a drug that helped save my life? Thats inspiring, and one of my roles as an ambassador is to show how incredible this organization is.

What is something that you wish more people knew about cancer?

Every 10 minutes, someone is diagnosed with lymphoma in the United States. To me, thats not okay, and it is a disease that affects young adults. If youre a young adult living in the United States and youre diagnosed with cancer, most likely it is going to be lymphoma. Whats been really interesting since I returned to Survivor is that Ive connected with fans over social media. Since Im so accessible now, Ive gotten many emails and DMs from fans who are like, "I saw your symptoms and because of that I went to the doctor and got diagnosed." Its been worthwhile to share my story, to work with LRF, and to help amplify that story.

Ethan Zohn is sharing details of being a lymphoma survivor. (Photo: Ethan Zohn)

What was your most meaningful reality TV experience?

Ive been on a lot of reality shows, some Im proud of and some Im not. You can guess from IMDb which ones those are. [Laughs] But on Survivor: Africa, I won a reward challenge where I received two goats. I had to take these little goats to an African village, and before I went into town I was hanging out with these kids in the parking lot of a hospital. They were touching my skin, my hair they had never seen someone who looked like me before. I took out my luxury item, a hacky sack, and we started playing. We were having an incredible time playing and laughing speaking the same language through the game of soccer. Before I left, I asked a nurse why all the kids were hanging out by the hospital? And she said, "These are the kids who are HIV positive."

Here I was, in the middle of this cutthroat game of Survivor, and I had that real-life experience. It was the first time I saw how this disease was really affecting the community. Thats when I decided to start a charity to help kids. Now, Grassroot Soccer is in 60 countries and weve graduated 13 million kids from the program all from a silly little reality show! People often look at reality TV a certain way, but if I didnt win Survivor and that money, in that moment in the center of the AIDS pandemic, who knows what would have happened.

Who would you love to compete with in your ideal game of Survivor?

I wouldnt necessarily want to compete with these people, but Id like to hang out with them on an island. Id like to play against [Portuguese soccer player] Cristiano Ronaldo. Id like to bring my dad back and play with him. And Bob Marley, because Im a huge Bob Marley fan. Ive always wanted Survivor to do a global version of Survivor. Take the winner from each country playing Survivor, and well all play against each other. I think there are 23, 24 different countries playing Survivor.

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'Survivor' winner Ethan Zohn opens up about his cancer battle: I was a healthy, young guy. You never expect it to be you. - Yahoo Life

The Best Skincare Treatments For Time-Crunched Moms (Or Anyone Else Who Only Has Five Minutes To Spare) – Forbes

As a beauty writer and longtime skincare fanatic, Ive subscribed to various multi-step routines. Fast forward to having a baby and the general day-to-day life upheaval that comes along with it, and my definition of a worthwhile personal beauty regimen has changed a bit. While I still enjoy trying new products and learning about innovations in the beauty space, I find myself with less time (and patience) for the more laborious treatments and layering routines, and more interest in noticeable efficacy and multitasking capabilities.

The most effective skincare products and tools are great for paring down your routineand also ... [+] saving you some precious minutes in your day.

And whether youre a busy mom or simply short on me time these days (who isnt?), there are a myriad of tried-and-true products that get the job done without requiring a ton of effort on your part. From Herauxs next-level anti-inflammaging serum to NuFaces skin-smoothing device, these standout skincare products and tools are ideal for a results-driven regimen thats effective enough to knock a few steps off your routineand save you some precious minutes in your day.

Since its launch seven years ago, this antioxidant-rich hydrating facial oil has remained a cult favorite for anyone who wants an instant glow, with the added benefit of skin soothing, balancing and repair. Infused with 22 active botanical and essential oils, the lightweight yet potent treatment can help with everything from acne to sun damage. And when applied using founder April Gargiulos signature push-press technique, it feels like a simple yet luxurious way to start and end the day.

Like the brands Trinity device, the NuFace Fix uses microcurrent technology at a gentler level to help reduce the look of fine lines and wrinkles on the more delicate areas of the face: on the forehead, between brows and around the eyes and lips (filler-free plumping, anyone?). Its sleek, compact shape combined with ease of use makes it a no-brainer for skin smoothing results in a matter of minutes. Plus, it holds an ample 120-minute charge, which amounts to a couple months worth of use before needing to plug it ini.e. no fumbling with cords or a hefty device on a regular basis.

The latest product in Kate McLeods sustainably packaged, handcrafted self care collection and the first to focus on skincare, the Face Stone is essentially a waterless moisturizer that melts on contact with skin. A rich blend of nourishing and antioxidant ingredients like blue tansy, kokum butter and plum kernal borage helps even and soothe stressed skinsomething we could all use these days. An added bonus? Its solid form and shape makes it a natural massaging tool, making it ideal for a morning pick-me-up or the start of an evening wind-down ritual.

While it covers your mineral-based broad spectrum sunscreen needs, this multitasker does much more than that. The unique product uses the U Beautys proprietary Sun-Siren Capsule Technology to help reduce hyperpigmentation, discoloration and dark spots (whether from pregnancy melasma or suntanning sins of the past) while also shielding against UVA, UVB, infrared and blue light exposure. A little goes a long way with this rich balm-cream formula, and its hydrating enough to double as a moisturizer or primer by day and also great as an overnight spot treatment.

An excellent (and cleaner) dupe for Biologique Recherches oft-elusive Lotion P50, this Moon Juice exfoliator is a skin savior in its own right. The liquid formula includes glycolic, lactic and salicylic acids for gentle, pore-minimizing exfoliation paired with niacinamide and adaptogenic reishi to help boost the skins natural barrier. And besides looking pretty, the packaging is completely recyclable, from the sculptural cap and glass bottle to the outer carton.

January Labs is a clean beauty favorite for its science-backed, results-driven products that have long been favored by top aestheticians. Even those with more sensitive (or dry) skin can use this retinol serum without dealing with typical downsides (like redness, drying or peeling) thanks to its use of Retistar, a .5% retinol thats super effective yet non-irritating.

This at-home peel is as easy as can be, requiring a single once-over with the pre-soaked pad to revive dull skin. The duo of glycolic and salicylic acids provide skin-smoothing exfoliation while ingredients like chamomile and bilberry extract calm, soothe and help even skin tone. Pro tip: Use up excess product on any dry, flakey patches on arms and legs.

Created by stem cell biologists at the University of Southern California, this innovative serum features an anti-inflammaging HX-1 molecule thats combined with tried-and-tested ingredients like vitamin C, hyaluronic acid, peptides and red maple bark. The result? A silky, lightweight formula thats both rejuvenating (designed to help reduce the effects of stress and aging factors on skin) and preventative (strengthening stem cells on a molecular level).

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The Best Skincare Treatments For Time-Crunched Moms (Or Anyone Else Who Only Has Five Minutes To Spare) - Forbes