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Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals.

On August 9, 2023, the FDA granted accelerated approval to talquetamab-tgvs (brand name Talvey) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Efficacy was evaluated in MMY1001, a single-arm, open-label, multicenter study that included 187 patients who had previously received at least four prior systemic therapies. Patients received talquetamab-tgvs 0.4 mg/kg subcutaneously weekly, following two step-up doses in the first week of therapy, or talquetamab-tgvs 0.8 mg/kg subcutaneously biweekly, following three step-up doses, until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate and duration of response as assessed by an Independent Review Committee using International Myeloma Working Group criteria. The primary efficacy population consisted of patients who had previously received at least 4 prior lines of therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Overall response rate in the 100 patients receiving 0.4 mg/kg weekly was 73% and median duration of response was 9.5 months. Overall response rate in the 87 patients receiving 0.8 mg/kg biweekly was 73.6% and median duration of response was not estimable. An estimated 85% of responders maintained response for at least 9 months.

The prescribing information for talquetamab-tgvs has a Boxed Warning for life threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity. Because of the risks of cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity, talquetamab-tgvs is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (or REMS), called the Tecvayli-Talvey REMS.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

On August 14, 2023, the FDA granted accelerated approval to elranatamab-bcmm (brand name Elrexfio), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Efficacy was evaluated in MagnetisMM-3, an open-label, single-arm, multi-center study that included patients with relapsed/refractory multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody. Patients had measurable disease by International Myeloma Working Group criteria at enrollment.

The main efficacy outcome measures were objective response rate and duration of response, as assessed by a blinded independent central review based on International Myeloma Working Group criteria. The primary efficacy population consisted of 97 patients naïve to prior B-cell maturation antigen-directed therapy and who had previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The objective response rate in the 97 patients receiving the recommended dose was 57.7%. With a median follow-up of 11.1 months among responders, the median duration of response was not reached. The duration of response rate at 6 months was 90.4% and at 9 months was 82.3%.

The prescribing information for elranatamab-bcmm has a Boxed Warning for life threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity. Among patients who received elranatamab-bcmm at the recommended dose, cytokine release syndrome occurred in 58% of patients, neurologic toxicity in 59%, and immune effector cell-associated neurotoxicity in 3.3%. Grade 3 cytokine release syndrome occurred in 0.5% of patients and Grade 3 or 4 neurologic toxicity occurred in 7%.

Because of the risks of CRS and neurologic toxicity, including ICANS, elranatamab-bcmm is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (or REMS), called the ELREXFIO REMS.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.

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