Bristol Myers Squibb’s CAR-T therapy Breyanzi scored its third approval over the last several months, this time in the third-line setting for adults with relapsed or refractory mantle cell lymphoma, a rare and aggressive form of non-Hodgkin lymphoma.
The company noted that this is the one-time infusion’s fourth approval in subtypes of non-Hodgkin lymphoma. The FDA based its approval on the Phase 3 TRANSCEND NHL 001 trial, with 85.3% of patients on Breyanzi responding to treatment, 67.6% achieving a complete response and just over 50% of patients still responding after 12 months. The median duration of response was 15.7 months.
Bristol Myers added that in order to meet the demand following this new approval, it has made “continuous investments” to increase manufacturing capacity. The drug pulled in $107 million in the first quarter of 2024 and $364 million in 2023, according to the company’s latest financial report.
In safety, 54% of patients experienced cytokine release syndrome, with 3.2% experiencing higher than a grade 3 event and 31% of patients experiencing a neurological event. Breyanzi currently has a boxed warning for both side effects, as well as for T cell malignancies.
Michael Wang, the trial’s lead investigator and professor at the University of Texas MD Anderson Cancer Center, said in a statement that this form of non-Hodgkin lymphoma has seen “few advances” in its treatment “and prognosis worsens for patients after each subsequent relapse, often leaving them with high disease burden and difficulty achieving deep and durable responses.”
Earlier in May, Breyanzi earned an accelerated approval from the FDA in the third-line setting for adult patients with relapsed or refractory follicular lymphoma. In March, it also added another accelerated approval in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
According to the company’s website, Breyanzi is in a range of other lymphoma trials, including in chronic lymphocytic leukemia and pediatric B cell acute lymphoblastic leukemia, among others.