ARTICLE | Clinical News

Kyprolis carfilzomib regulatory update

September 14, 2015 7:00 AM UTC

Amgen submitted an sNDA to FDA for Kyprolis carfilzomib to treat relapsed multiple myeloma (MM) in patients who have received >=1 prior therapy. The sNDA is based on data from the international Phase III ENDEAVOR trial comparing Kyprolis with low-dose dexamethasone vs. Velcade bortezomib with low-dose dexamethasone in 929 patients with relapsed MM following treatment with 1-3 prior regimens (see BioCentury, March 9). An MAA is under accelerated assessment in Europe for MM patients who have received >=1 prior therapy. ...