The Food and Drug Administration will review data on Breyanzi (lisocabtagene maraleucel) — a CAR-T cell therapy — for use in the second-line setting for patients with relapsed or refractory large B-cell lymphoma to determine if the indication will be granted approval.
The Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for Breyanzi (lisocabtagene maraleucel) for adults with relapsed or refractory large B-cell lymphoma (LBCL) after progression or lack of response to a frontline therapy, according to Bristol Myers Squibb, the manufacturer of the CAR-T cell therapy.
The FDA will now review data regarding the drug and plans to decide on whether to approve Breyanzi by June 24, 2022.
Of note, the FDA may make a decision before or after the expected date.
“This acceptance from the FDA brings us one step closer to delivering a practice-changing treatment for primary refractory or relapsed large B-cell lymphoma, making Breyanzi available to more patients in need, and underscores the advancements we’re making in cell therapy research to transform the lives of patients with difficult-to-treat blood cancers, including lymphoma,” Anne Kerber, senior vice president of Cell Therapy Development at Bristol Myers Squibb said in a statement.
The sBLA was granted based on results from the global, randomized, phase 3 TRANSFORM clinical trial, that compared results of second-line Breyanzi with standard of care (salvage chemotherapy then high-dose chemotherapy plus autologous hematopoietic stem cell transplant) in adults with relapsed or refractory LBCL.
TRANSFORM’s main goal was to evaluate event-free survival (which is time from randomization to death of any cause, progressive disease, failure to achieve a complete or partial responseby nine weeks, or the start of a new therapy), which was much better in the Breyanzi group compared to the standard of care group (10.1 months versus 2.3 months, respectively), according to data presented at the 2021 ASH Annual Meeting and Exposition.
Researchers also looked at the percentage of patients in each group who responded to treatment, known as overall response rate (ORR). The ORR was 44% in the standard of care arm, with 36% achieving a complete response (CR), meaning that there was no detectible amount of cancer after treatment. The Breyanzi group had a 70% ORR, with 61% of patients achieving a CR.
On average, patients on Breyanzi lived longer before their disease got worse compared to those on standard of care (average of 14.8 months compared to 5.7 months), and had longer overall survival, too (average not reached, compared to 16.4 months).
While these findings are promising, there are potentially dangerous side effects that patients with cancer should know about CAR-T cell therapies like Breyanzi, mainly cytokine release syndrome (where the body releases a high volume of an inflammatory agent called cytokines) and neurotoxicity. Patients receiving CAR-T cell therapies should be monitored for symptoms of these side effects immediately following treatment and should contact their health care providers immediately if they start to experience symptoms in the weeks after treatment, according to a statement from Bristol Myers Squibb.
If granted FDA approval, Breyanzi will move up from being previously approved in the third-line setting to the second-line.
“Breyanzi as a differentiated CD19-directed CAR T cell therapy has already proven to be an important treatment option for patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy and now has the potential to be a new standard of care for patients after failure of first-line therapy, offering significantly improved outcomes beyond the current mainstay of care,” Kerber said.
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