FDA Grants Accelerated Approval to Teclistamab for Relapsed/Refractory MM

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for the use of teclistamab in adults with relapsed or refractory multiple myeloma who have received at least four previous lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Teclistamab, a first-in-class bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, was evaluated in 110 patients in the single-arm, multi-cohort, open-label, multi-center MajesTEC-1 phase I/II study.

The overall response rate, which was the main efficacy measure in the study, was 61.8%, with an estimated duration of response rate of 90.6% at six months and 66.5% at nine months, according to the FDA.

“In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated patients with relapsed or refractory multiple myeloma,” said Ajai Chari, MD, Professor of Medicine, Division of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai and study investigator, in a press release issued by the Janssen Pharmaceutical Companies of Johnson & Johnson. “As a clinician and researcher, I see first-hand the human toll of this incurable disease. The approval of teclistamab, as the first bispecific antibody in relapsed or refractory multiple myeloma, is a meaningful step in helping many of these hard-to-treat patients.”

The recommended dose of teclistamab is 0.06 mg/kg via subcutaneous injection on day one, 0.3 mg/kg on day four, and 1.5 mg/kg on day seven, followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.

The prescribing information for teclistamab has a boxed warning for “life threatening or fatal” cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity, according to the FDA.

The FDA granted the application priority review and the treatment also received orphan drug designation and breakthrough designation. The application review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

The FDA accelerated approval for teclistamab follows the European Commission’s Conditional Marketing Authorization for teclistamab as a monotherapy for the treatment of adults with triple-class exposed relapsed/refractory multiple myeloma.

Sources: Janssen Pharmaceutical Companies of Johnson & Johnson; U.S. Food and Drug Administration, October 2022