Gilead’s Kite Pharma gets FDA nod for second CAR-T cell therapy

The agency approved Tecartus, previously developed under the name KTE-X19, as the first CAR-T therapy for mantle cell lymphoma. The company had previously won approval for another CAR-T, Yescarta. Tecartus is a similar product, but with a different manufacturing process.

One of the first companies to win Food and Drug Administration approval for a CAR-T cell therapy has received the agency’s nod for its second product.

Kite Pharma, a subsidiary of Foster City, California-based Gilead Sciences, said Friday that the FDA had given accelerated approval to Tecartus (brexucabtagene autoleucel) as the first CAR-T cell therapy approved for mantle cell lymphoma, an indolent – or slow-growing – form of non-Hodgkin’s lymphoma. Kite had previously received approval for its first CAR-T, Yescarta (axicabtagene ciloleucel), for diffuse large B-cell lymphoma; Tecartus is a similar product to Yescarta and targets the same antigen, CD19, but uses a different manufacturing process, hence the different branding.

Shares of Gilead were down 2.5% on the Nasdaq following the news.

“Despite promising advances, there are still major gaps in treatment for patients with MCL who progress following initial therapy,” said Dr. Michael Wang, professor in The University of Texas MD Anderson Cancer Center’s Division of Cancer Medicine and lead investigator in the clinical trial that led to Tecartus’ approval, in a statement for Gilead. “Many patients have high-risk disease and are more likely to keep progressing, even after subsequent treatments.”

Several drugs are used to treat MCL, including Roche’s Rituxan (rituximab), which is usually combined with multiple chemotherapy drugs, as well as Bruton’s tyrosine kinase inhibitors like AbbVie and Johnson & Johnson’s Imbruvica (ibrutinib), BeiGene’s Brukinsa (zanubrutinib) and AstraZeneca’s Calquence (acalabrutinib).

The approval of Tecartus – developed under the name KTE-X19 – was based on results of the 105-patient Phase II ZUMA-2 study, which showed an 87% response rate in patients, including 62% who achieved a complete response. Cytokine release syndrome deemed severe or worse occurred in 18% of patients, while 37% experienced neurological toxicity that was deemed severe or worse.

Along with Yescarta, Novartis’ Kymriah (tisagenlecleucel) is also approved for DLBCL, in addition to its initial indication of acute lymphoblastic leukemia in children and young adults. Since the two CAR-Ts’ initial 2017 approvals, numerous other CAR-Ts have inched closer to the market as well, including in other cancer indications. A near-term potential competitor for Yescarta and Kymriah in DLBCL is BMS’ lisocabtagene maraleucel. BMS also has two CAR-Ts it is developing for multiple myeloma, namely orvacabtagene autoleucel and idecabtagene vicleucel, the latter of which is under a partnership with bluebird bio.

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