FDA approves Tecartus, first CAR T-cell therapy for mantle cell lymphoma
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The FDA granted accelerated approval to brexucabtagene autoleucel for treatment of adults with relapsed or refractory mantle cell lymphoma.
Brexucabtagene autoleucel (Tecartus; Kite Pharma/Gilead) is an autologous chimeric antigen receptor T-cell therapy that targets the CD19 protein on the surface of cancer cells. The U.S. list price will be $373,000 for a one-time infusion.
The agent becomes the third FDA-approved CAR T-cell therapy, and the second for Kite Pharma/Gilead.
The FDA previously approved axicabtagene ciloleucel (Yescarta; Kite Pharma/Gilead) in October 2017 for treatment of adults with relapsed or refractory large B-cell lymphoma. Another CAR T-cell therapy — tisagenlecleucel (Kymriah, Novartis) — is approved for treatment of certain patients with diffuse large B-cell lymphoma or B-cell acute lymphoblastic leukemia.
The FDA based approval of brexucabtagene autoleucel on results of the ongoing pivotal ZUMA-2 trial, which has enrolled 74 patients to date. The most recent efficacy results showed 87% of patients responded to one infusion of therapy. Researchers reported a 62% complete response rate at minimum follow-up of 6 months.
"This is an incredibly exciting advancement in the treatment of mantle cell lymphoma, which is historically an incurable lymphoma with relatively short survival when chemotherapy stops working,” Caron Jacobson, MD, medical director of the immune effector cell therapy program at Dana-Farber Cancer Institute and an investigator on the ZUMA-2 trial, told Healio. “The responses seen in the ZUMA-2 trial in very high-risk and heavily pretreated patients with mantle cell lymphoma are phenomenal and, although longer follow-up is needed, many persist beyond the 1-year mark, suggesting that this therapy has the potential to make a substantial impact on the natural history of this disease."
The typical prognosis for the patient population in ZUMA-2 is poor, according to Ken Takeshita, MD, senior vice president of clinical development at Kite Pharma. Those treated with brexucabtagene autoleucel had undergone multiple lines of therapy.
“To achieve a response rate of over 90% with two-thirds of patients achieving complete remission is truly remarkable,” he told Healio. “The efficacy data on this one-time treatment is truly outstanding and it offers patients an additional option over existing approved therapies.”
Safety results from ZUMA-2 show that 18% of patients experienced grade 3 or higher cytokine release syndrome (CRS), whereas 37% had some form of neurotoxicity. The most common grade 3 or higher adverse events included anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy, leukopenia, hypoxia, pyrexia, hyponatremia, hypertension, unspecified infection-pathogen, pneumonia, hypocalcemia and lymphopenia.
Brexucabtagene autoleucel will include a boxed warning that outlines risks for CRS and neurotoxicity associated with CAR T-cell therapy. The FDA has combined its posttreatment Risk Evaluation and Mitigation Strategy monitoring program for both Kite Pharma/Gilead-approved CAR T-cell therapies into what is now called the Yescarta and Tecartus REMS Program.
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