Glenmark Pharmaceuticals Gets CDSCO Panel Nod To Import and Market anticancer Drug Zanubrutinib Capsules 80mg
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New Delhi: Pharmaceutical major Glenmark Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the anticancer drug, Zanubrutinib Capsules 80 mg, with a local Phase III clinical trial waiver.
However, this approval is subject to the condition that the firm should conduct a structured Phase-IV clinical trial in which all five indications are included.
This came after Glenmark Pharmaceuticals presented the proposal for import and marketing of the drug, Zanubrutinib Capsules 80 mg, along with justification of a local Phase III clinical trial waiver before the committee.The firm presented the global clinical data for the safety and efficacy of the drug.
The committee deliberated in detail on unmet medical needs along with long-term studies on progression-free survival. The committee noted that the drug falls under unmet medical need.
The committee agreed for the local Phase III clinical trial waiver. The committee noted that the drug is approved in 72 countries, including the US, Australia, Canada, EU, and UK.
Zanubrutinib is a novel Bruton's tyrosine kinase (BTK) inhibitor used for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Mantle cell lymphoma is an aggressive mature B-cell non-Hodgkin lymphoma associated with early relapse, poor clinical outcomes, and long-term survival. BTK is an enzyme that plays a role in oncogenic signalling pathways, promoting the survival and proliferation of malignant B cells.
Zanubrutinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Zanubrutinib forms a covalent bond with a cysteine residue in the active site of BTK, which inhibits BTK activity. This prevents the signaling pathways that are necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
At the recent SEC meeting for Oncology held on 5th December 2024, the expert panel reviewed the proposal for import and marketing of the drug, Zanubrutinib Capsules 80mg, along with justification of the local Phase-III clinical trial waiver before the committee.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug, Zanubrutinib Capsules 80 mg, with a local Phase III clinical trial waiver with the condition to conduct a structured Phase IV clinical trial in which all five indications are included.
In addition, the expert panel suggested the firm submit the Phase-IV study protocol to the CDSCO within the period of three months of approval of the drug for further review by the committee.
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