Gilead to get speedy FDA review for second CAR-T cell therapy in lymphoma

The biotech company’s Kite Pharma subsidiary said the FDA had granted priority review for KTE-X19 in mantle cell lymphoma. The company already markets the CAR-T Yescarta for diffuse large B-cell lymphoma.

A subsidiary of Gilead Sciences could have its second CAR-T cell therapy on the market by this summer if the Food and Drug Administration rules in its favor.

Foster City, California-based Gilead’s subsidiary, Kite Pharma, said Monday that the FDA had given priority review to its regulatory approval application for KTE-X19 in patients with relapsed or refractory mantle cell lymphoma, or MCL. The company already markets one of the two CAR-Ts currently on the market, Yescarta (axicabtagene ciloleucel), for patients with diffuse large B-cell lymphoma; the other approved therapy is Novartis’ Kymriah (tisagenlecleucel).

The FDA is expected to decide on whether to approve KTE-X19 by Aug. 10.

Shares of Gilead were up slightly in premarket trading on the Nasdaq Monday.

MCL and DLBCL are both subtypes of non-Hodgkin’s lymphoma, with MCL being a slow-growing form of the disease. KTE-X19 is similar to Yescarta and has the same antigen target, CD19, but uses a different manufacturing process.

Kite filed for approval of KTE-X19 in December and subsequently filed for approval with the European Medicines Agency, which has also certified its application. The submissions were based on data from the Phase II ZUMA-2 study, which were presented at the American Society of Hematology in early December. The data showed that among 60 patients evaluable for efficacy, 93% responded to the CAR-T, including 67% who achieved complete responses. Among those who responded to therapy, 57% remained in response after a median follow up of 12.3 months, with rates of progression-free survival and overall survival at the 12-month mark of 61% and 83%, respectively.

Cytokine release syndrome and neurological toxicity – two side effects frequently associated with CAR-T therapies – occurred in 91% and 63% of patients, respectively, with events rated as severe or worse respectively occurring in 15% and 31%. However, there were no fatalities resulting from toxicity.

Yescarta and Kymriah both won FDA approval in 2017, and CAR-T development has come a long way since then. In addition to KTE-X19, other CAR-T therapies up for FDA approval include two from Bristol-Myers Squibb, namely lisocabtagene maraleucel and idecabtagene vicleucel. The former would be approved for DLBCL, while the latter would be for multiple myeloma and is being developed under a partnership with bluebird bio.

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