FDA grants priority review to Kyprolis and approves label update for Zytiga

The US Food and Drug Administration has granted priority review for Kyprolis (carfilzomib) from Amgen (Nasdaq: AMGN) and has approved a label update for Zytiga (abiraterone acetate) from Janssen, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ).

The FDA accepted the supplemental New Drug Application of Kyprolis for injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. This sNDA is designed to support the conversion of accelerated approval to full approval, and expand the current indication for Kyprolis. It has a Prescription Drug User Fee Act target action date of July 26, 2015.

Kyprolis is currently approved by the FDA for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy.