Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

The first approved indication is in second-line DBLCL, for patients ineligible for autologous stem cell transplant. Mizuhos Mara Goldstein estimated that market at around 6,000 US patients and said the drug had blockbuster potential, but she noted those patients have several other options available to them.

The initial market opportunity as a second-line treatment is meaningful, she wrote in a note to investors, though we are somewhat cautious on the ramp of the drug given the competitive landscape for this indication that includes seven drug regimens as well as treatment with CAR-T therapy.

SVB Leerinks Geoffrey Porges called the approval a best case scenario, noting it had been unclear whether the drug would be approved for second-line or third-line therapy. He estimated a potential patient population around 12,000.

Both analysts singled out Monjuvis duration in particular. The 21.7 months it showed at the top line readout is more than twice the 6 months to a year Roches antibody-drug Polivy, approved last year, has shown.

We believe the CAR-T like efficacy demonstrated by tafa, as well as its favorable safety profile should enable broad adoption in the 2L setting, Porges wrote in a note to investors, and expect the product to be preferred over Roches CD79 ADC Polivy.

Former MorphoSys CEO Simon Moroney positioned Monjuvi as an option for patients who cant handle the intense bodily stress of high-dose chemotherapy or stem cell transplant, or of CAR-T. In addition to the costly and lengthy process of extracting, treating and re-implanting T cells, CAR-T therapies also require patients to undergo conditioning regimens of intensive chemotherapy to clear out the bone marrow and essentially give a pocket for the new cells to take hold.

By contrast, Monjuvi is an anti-CD19 antibody that is given intravenously and requires no conditioning.

Our patients tend to be older median age in the trial is 72, Moroney told MedCity Newslast June, referring to participants in their pivotal Phase II study. They have comorbidities and are not eligible for CAR-T.

The FDA decision is an accelerated approval based on results from that Phase II study. Topline results released last year showed a 55% overall response rate and a 37% complete response rate. The latest data, released in May, showed a 59% response rate, a 39% complete response rate, and a median duration of response that had risen to 34.6 months nearly 3 years. The complete response rates were in line with the early CAR-T trials, and the FDA granted the drug priority review.

Both MorphoSys and Incyte have staked a lot on Monjuvi. MorphoSys raised $208 million in an IPO in 2018, funneling much of that cash into building out a US commercial operation in anticipation of their lead drugs approval. They tapped the US commercial lead for Merck KGaAs Bavencio, David Trexler, to lead that effort. And after Moroneys retirement, Jean-Paul Kress stepped in to lead a new stage for the company.

Incyte, meanwhile, spent $900 million earlier this year to join with Incyte on the commercial launch, hoping the CAR-T alternative could pour some oil into a sputtering R&D engine. Mizuhos Goldstein said the drug would help diversify Incytes revenue base, but its overall impact may be muted.

Monjuvi may not have enough impact in the near term to alter the fundamental picture for the company, she said of Incyte.

Goldstein also called the drug validation for Xencors platform. The California biotech originally developed the antibody. The approval triggered a $25 million milestone for them.

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FDA hands MorphoSys and Incyte a quick OK on their potential blockbuster CAR-T alternative - Endpoints News