Multiple Myeloma | News | Blogs | FDA and EMA approvals | Updates on clinical guidelines

Janssen announced that it had submitted a biologics license application of teclistamab to the US FDA for relapsed or refractory multiple myeloma.

The approval is based on the MajesTEC-1 (NCT04557098, NCT03145181) trial, which evaluated the efficacy and safety of teclistamab in patients with relapsed or refractory multiple myeloma. The investigators have considered the overall response rate, very good partial response, and complete response to determine efficacy and safety. In the trial, the overall response rate after a median follow-up of eight months is 62%. Fifty-eight percent of patients showed very good partial response, 29% showed complete response, and 21% achieved stringent complete response. Overall survival was not reached; the PFS rate at nine months is 59%.

Teclistamab is a T-cell redirecting antibody targetting both BCMA and CD3. It has received orphan drug designation from EMA and the US FDA. It also received PRIME designation from the European Medicines Agency and a Breakthrough Therapy Designation from the FDA.


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