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.
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