FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion
An FDA advisory committee is meeting on Thursday to weigh a potential label expansion for Roche’s potential blockbuster Polivy, but the agency has some concerns about efficacy and safety.
The pharma giant will come before the Oncologic Drugs Advisory Committee (ODAC) on Thursday to discuss data from the Phase III Polarix trial, originally intended to meet a post-marketing requirement, and see if Polivy can be used for patients with earlier lines of diffuse large B-cell lymphoma (DLBCL).
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