ODAC to debate Roche's Polivy in first-line DLBCL following 2019 accelerated approval
Once again the FDA’s panel of outside oncology experts will have to weigh in on whether or not to grant another indication for Roche’s potential blockbuster cancer drug Polivy, which some analysts have said could reap $2.4 billion in peak annual sales.
Approved in June 2019 under the accelerated pathway, the antibody drug conjugate Polivy was OK’d in combo with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
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