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

November 07, 2022

Blenrep failed to demonstrate superior PFS versus PomDex in RRMM patients

GSK announced that Blenrep (belantamab mafodotin) was unable to meet the primary endpoint of showing superior progression-free survival (PFS) versus pomalidomide plus low-dose dexamethasone (PomDex) in patients with relapsed or refractory multiple myeloma.

DREAMM-3 is a Phase 3 open-label, head-to-head trial; progression-free survival was the primary endpoint. The progression-free survival was 11.2 months in Blenrep vs. seven months in patients on PomDex. The secondary endpoints are overall response rate (ORR), duration of response (DOR), and overall survival (OS). The ORR was 41% in the Blenrep arm versus 36% in patients on PomDex.

The US Food and Drug Administration (FDA) granted accelerated approval for Blenrep in adult patients with RRMM previously treated with four lines of therapy.

Blenrep is in evaluation for earlier lines of treatment for patients with relapsed or refractory multiple myeloma.


June 29, 2022

Talquetamab received FDA breakthrough designation for treating relapsed or refractory multiple myeloma.

Janssen Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation to talquetamab for treating adult patients with relapsed or refractory multiple myeloma.

Talquetamab is indicated in patients who were treated with at least four treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

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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