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.
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