CDSCO Panel approves Roche Products' Polatuzumab Vedotin for Injection 30mg per vial for Diffuse large B-cell lymphoma
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Roche's proposal for the additional indication of diffuse large B-cell lymphoma (r/r DLBCL) for Polatuzumab Vedotin for injection (Polivy) 30 mg/vial with the condition that the drug should be prescribed only for the patients who are not eligible for transplant procedure as certified by the tumor board of the hospital.
This came after Roche Products (India) presented the proposal for grant of approval of additional indication of diffuse large B-cell lymphoma (r/r DLBCL) for the already approved drug Polatuzumab Vedotin for injection (Polivy) 30 mg/vial.
The committee noted that the proposed indication is already approved for the other pack presentation, i.e 140 mg/mL of the same drug, and there is no change in the approved strength of the drug, the anti-cancer drug Polatuzumab Vedotin, for an additional indication "for the treatment of diffuse large B-cell lymphoma (r/r DLBCL) for the already approved drug Polatuzumab Vedotin for injection (Polivy) 30 mg/vial."
Polatuzumab vedotin is a CD79b antibody conjugate indicated to treat different types of large B-cell lymphoma.
Polatuzumab vedotin is a CD79b-directed antibody-drug conjugate that delivers monomethyl auristatin E (MMAE), an anti-mitotic agent, to cancer cells. The drug consists of three components: a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b (polatuzumab), MMAE, and protease-cleavable linker called maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB) that covalently attaches MMAE to polatuzumab.
At the recent SEC meeting for Oncology, the expert panel reviewed the proposal for grant of approval of additional indication of diffuse large B-cell lymphoma (r/r DLBCL) for the already approved drug Polatuzumab Vedotin for injection (Polivy) 30 mg/vial.
After detailed deliberation, the committee recommended the grant of approval of additional indication for the pack presentation of Polatuzumab Vedotin for injection (Polivy) 30 mg/vial with the condition of the initial approval of Polatuzumab Vedotin (Polivy) 140 mg/vial for injection, i.e., “The drug should be prescribed only for the patients who are not eligible for transplant procedure as certified by the tumor board of the hospital.”
Accordingly, the expert panel stated that the revised prescribing information (PI) shall be submitted to CDSCO.
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