2024-04-07 16:42:28
“CAR-T” achieved a complete response of 20% and sustained remission for 35 months!! FDA approved Bristol-Myers Squibb’s Breyanzi as the first CAR-T therapy for two types of leukemia
On April 4, 2024, the U.S. FDA approved Breyanzi, a CAR T cell therapy targeting CD19 by Bristol-Myers Squibb, for the treatment of relapsed or refractory patients who have been treated with Bruton tyrosine kinase inhibitor (BTKi) and lymphoma 2 inhibitor (BCL2i). Treatment-resistant chronic lymphocytic leukemia (CLL) small lymphocytic leukemia (SLL).
BTKi and BCL2i therapies are the most common and effective treatment options for CLL. Still, when patients fail on both fronts, the prognosis is dire, and until the FDA approves Breyanzi, they really have few effective treatment options. Breyanzi will provide one of the options for patients who have failed traditional treatments.
Bristol-Myers Squibb hopes to expand Breyanzi’s therapy into the treatment market.For the treatment of patients with relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma who have received BTKi therapy. The company’s PDUFA dates are May 23, 2024 and May 31, 2024.Day.
Clinical Trials
1. Announcement in May 2023 that in the pivotal TRANSCEND 004 trial, 18.4% of patients with CLL or SLL had a complete response (CR) to Breyanzi treatment at 21.1 months of follow-up, with an overall response rate (ORR) of 42.9%. April 4, 2024, the latest test results,Breyanzi was shown to have a CR rate of 20%, an overall response rate (ORR) of 45%, and responses lasting over 35 months.. Rosanna Ricafort, Vice President and Head of Late Stage Development Hematology and Cellular TherapiesEmphasizes the importance of a 20% CR rate as complete responses are essentially unheard of in this patient population with relapsed/refractory CLL among currently available therapies。(Further reading: “CAR-T” Up to 50% of patients who received CAR-T relapsed within one year following treatment!! Autologous and allogeneic cell therapies each have their own merits (read))
2. Bristol-Myers Squibb stated that Breyanzi demonstrated a “controlled safety profile” in TRANSCEND CLL 004. CAR T cells do have potentially life-threatening toxicities. They must be administered by caregivers with expertise in administering CAR T cells.
FDA black box warning
For CLL and SLL, FDA appendedCytokine release syndrome, neurotoxicityand a boxed warning for secondary hematologic malignancies.The first two risks occur specifically with Breyanzi, and the third risk is related to BCMA and CD19-directed CAR-T therapies, including Breyanzi. With Thursday’s approval of Breyanzi for CLL and SLL, the FDA is clearly willing to expand CAR T therapy into more tumor indications.
The FDA is carefully evaluating these and other risks when it comes to CAR-T therapies. In November, regulators launched an investigation into the “serious risk” of secondary malignancies, resulting in black box warnings being added to all six commercial CAR-T therapies at the time. (Further reading: The latest problem in “CAR-T” cell therapy – secondary T cell cancer following treatment!)
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