CDSCO Panel Approves Roche's Protocol Amendment Proposal to Study Polatuzumab Vedotin
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment proposal presented by the drug major Roche to study the anticancer drug Polatuzumab vedotin.
This came after the drug major Roche presented the proposal along with protocol amendment no. 8.0 dated 19--October 2022 in Global Clinical Trial protocol no. MO40598 for approval before the committee.
Polatuzumab vedotin is a CD79b antibody conjugate indicated to treat different types of large B-cell lymphoma.
Polatuzumab vedotin is combined with bendamustine and rituximab to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. In Canada, this indication is approved for patients who are not eligible for autologous stem cell transplant and have received at least one prior therapy.
Polatuzumab vedotin is also used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) to treat adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high-grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.
After binding to CD79b on the B-cell surface, polatuzumab vedotin is internalized and the linker cleaved, releasing MMAE into the cell, inhibiting division and inducing apoptosis.
At the recent SEC meeting for Oncology and Hematology held on 8th June 2023, the expert panel reviewed the proposal along with protocol amendment no. 8.0 dated 19--October 2022 in Global Clinical Trial protocol no. MO40598 of the anti-cancer drug Polatuzumab Vedotin.
After detailed deliberation, the committee recommended the grant of approval for the protocol amendment as presented by the firm.
