FDA Calendar

Company Name Roche Holding AG
Drug Name POLIVY (sBLA)
Event Name FDA panel to review POLIVY for expanded use in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma
Event Date 03/09/2023
Outcome Date 03/09/2023
Outcome FDA panel voted 11 to 2 in favour of Polivy in combination with R-CHP for people with previously untreated diffuse large B-cell lymphoma on Mar.9, 2023
Drug Status
Rival Drugs
Market Potential POLIVY recorded net sales of CHF 437 million in full-year 2022, up 85% over 2021
Other Approvals POLIVY was approved by the FDA in June 2019 for use in combination with bendamustine and rituximab for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, who have received at least two prior therapies.
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