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).
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).
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.
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.