Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) has been recommended by the European Medicines Agency’s human medicines committee to treat follicular lymphoma (FL).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the CD19-directed CAR T cell therapy, which is already approved in the EU for certain lymphomas, be authorised to treat adults with relapsed or refractory FL who have received at least two prior lines of systemic therapy.
FL develops when white blood cells cluster together to form lumps in the lymph nodes or organs and is the second most common form of non-Hodgkin lymphoma, accounting for up to 30% of all cases.
The disease is considered incurable, with patients frequently relapsing following front-line therapy and the prognosis worsening after each subsequent relapse.
Breyanzi is made from patients’ own T cells, which are collected and genetically re-engineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
The CHMP’s recommendation of the therapy was supported by positive results from the mid-stage TRANSCEND FL study, which demonstrated an overall response rate of 97.1% and a complete response rate of 94.2%, the trial’s primary and key secondary endpoints, respectively.
Responses were rapid and durable, BMS said, with 75.7% of patients in response at 18 months, and the safety of Breyanzi was consistent with its established safety profile observed across clinical trials.
The European Commission will now receive the CHMP’s recommendation as it makes a decision on Breyanzi in this indication.
Anne Kerber, senior vice president, head of late clinical development, haematology, oncology and cell therapy at BMS, said: “This is another important step in our commitment to delivering Breyanzi to more patients across indications, as well as expanding into new regions, especially for diseases with continued unmet need such as relapsed or refractory FL, which is considered incurable.”
Alongside the positive opinion for Breyanzi, BMS has also received a recommendation from the CHMP for the use of its dual immunotherapy combination in hepatocellular carcinoma, the most common type of liver cancer.
The committee has recommended that Opdivo (nivolumab) plus Yervoy (ipilimumab) be approved as a first-line treatment for adults with unresectable or advanced cases of the disease.