Roche gets CDSCO panel nod to import, market anticancer Drug Polatuzumab vedotin
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New Delhi: In a significant development, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to pharma major Roche for the import and marketing of the anti-cancer drug Polatuzumab Vedotin for Injection, 30 mg/vial and 140 mg/vial, with a waiver of Phase III clinical trials in the country and the condition that the firm should conduct a Phase IV trial.
This came after the firm presented its proposal for the import and marketing of the drug Polatuzumab Vedotin for Injection, 30 mg per vial and 140 mg per vial.
Polatuzumab Vedotin in combination with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Polatuzumab vedotin is a CD79b antibody conjugate used to treat different types of large B-cell lymphoma. It is manufactured by the pharma giant Roche under the brand name Polivy.
CD79b-directed antibody-drug conjugate (ADC) consisting of three components: the humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b, the small molecule antimitotic agent MMAE, and a protease cleavable linker maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB).
MMAE is an antimitotic agent covalently attached to the antibody via a cleavable linker. Monoclonal antibodies bind to CD79b, a B-cell specific surface protein, which is a component of the B-cell receptor. Upon binding CD79b, polatuzumab vedotin-piiq is internalized, and linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis
At the recent SEC meeting for oncology and hematology held on February 23, 2023, the expert panel reviewed the proposal presented by the pharmaceutical major Roche for the import and marketing of the drug Polatuzumab Vedotin for Injection, 30 mg per vial and 140 mg per vial.
The committee noted that the drug is approved in the EU, UK, Canada, Japan, China, Singapore, and Australia.
In addition, regarding the global clinical trial, the committee noted that global clinical trials are ongoing, in which India is also part of the trials.
Furthermore, the expert panel found that the drug falls under the category of an orphan drug, is indicated for the treatment of life-threatening diseases, and that there is an unmet medical need in the country.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug with the waiver of a Phase III clinical trial in the country, with the condition that the firm should conduct a Phase IV trial.
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