CDSCO panel rejects Pfizer Products India Local Clinical Trial Waiver Proposal for Elranatamab solution for injection
New Delhi: Reviewing the proposal presented by Pfizer Products India for grant of permission to import and market Elranatamab solution for injection 44 mg/1.1 mL (40 mg/mL) and 76 mg/1.9 mL(40 mg/mL), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the firm’s request for waiver of the local clinical trial for grant of permission to import and market Elranatamab solution for injection.
This came after the drug maker Pfizer Products India presented the proposal for a grant of permission to import and market Elranatamab solution for injections 44 mg/1.1 mL (40 mg/mL) and 76 mg/1.9 mL(40 mg/mL) along with a request for a local clinical trial waiver.
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 an accelerated approval (conditional approval) in the USFDA for proposed indication based on Phase II clinical trial data and the trial is ongoing.
Elranatamab is a bispecific antibody used to treat adults with relapsed or refractory multiple myeloma.
Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a humanized immunoglobulin 2-alanine kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb, each of which contributes one heavy chain and one light chain to drug structure.
Elranatamab is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma. In the US, it is approved in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
At the recent SEC meeting for Oncology held on 3rd and 4th April 2024, the expert panel reviewed the proposal presented by the drug major Pfizer for granting permission to import and market Elranatamab solution for injection 44 mg/1.1 mL (40 mg/mL) and 76 mg/1.9 mL(40 mg/mL) along with the request for local clinical trial waiver.
After detailed deliberation, the committee did not consider the firm’s request for waiver of the local clinical trial for grant of permission to import and market Elranatamab solution for injection.
