FDA granted accelerated approval to Polivy™
- Katrina Williams
- June 12, 2019
- No responses
The FDA granted accelerated approval to Polivy™, Genentech’s fifth blood cancer medicine. Polivy (polatuzumab vedotin-piiq) is a first-of-its-kind anti-CD79b antibody-drug conjugate used in combination with bendamustine plus Rituxan (rituximab) for people with diffuse large B-cell lymphoma (DLBCL) whose disease returned after or did not respond to multiple treatment regimens. The Genentech press release including Important Safety Information is linked here and a press release issued by the FDA about the approval is linked here.
- Polivy was discovered by Genentech scientists, and is the 17th medicine in its comprehensive cancer portfolio. The medicine builds upon the company’s history of antibody engineering and developing transformative medicines for people with serious and life-threatening diseases.
- DLBCL is the most common type of non-Hodgkin’s lymphoma, with nearly 25,000 new cases expected to be diagnosed in 2019.
- The disease becomes more difficult-to-treat upon multiple relapses or no response to treatment, and the Polivy combination offers a much-needed option that is available immediately.
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