New Delhi: Noting that no new data, literature, or updates have been presented by the firm, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected the drug major Pfizer Products India's proposal for waiver of local clinical trials for the grant of permission to import and market Elranatamab solution for injection.
Elranatamab is a bispecific antibody used to treat adults with relapsed or refractory multiple myeloma. Elranatamab is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma. In the US, it is approved for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
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.
After detailed deliberation, the committee reiterated the earlier SEC recommendation dated April 3, 2024, stating:
"The committee did not consider the firm’s request for waiver of local clinical trial for grant of permission to import and market Elranatamab solution for injection.”
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