CDSCO Panel Denies Pfizer Products India request for local CT waiver to market Elranatamab solution for injection

Elranatamab works by bringing healthy T cells (immune cells that help kill cancer cells) and myeloma cells close together so the T cells can more effectively kill the myeloma cells. It does this by binding to a protein called CD3 on healthy T cells and a protein called BCMA on myeloma cells.

At the recent SEC meeting for oncology held on June 5 and 6, 2024, the expert panel reviewed the proposal for the grant of permission to import and market Elranatamab solution for injection 44mg/1.1mL (40mg/mL) and 76 mg/1.9mL (40 mg/mL), along with a request for a local clinical trial waiver.

The committee noted that no new data, literature, or updates have been presented by the firm.

The drug is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.

The committee noted that the drug has accelerated approval (conditional approval) in the USFDA for the proposed indication based on Phase II clinical trial data, and the trial is ongoing.