Amgen Gets FDA Nod to Add ENDEAVOR Data on Kyprolis Label
Amgen, Inc. AMGN announced that the FDA has approved its regulatory application to include overall survival (OS) data from the head-to-head ENDEAVOR study on the label of its multiple myeloma drug, Kyprolis. Please note that the FDA’s decision comes much earlier than expected. It was initially expected in April.
Amgen had submitted the supplemental New Drug Application (sNDA) to the FDA in July last year. The regulatory application in the EU seeking approval to include OS data from ENDEAVOR study was also submitted in the same month.
Data presented from the ENDEAVOR study earlier had demonstrated that a combination of Kyprolis plus dexamethasone led to superior overall survival when compared to Takeda’s Velcade plus dexamethasone in second-line multiple myeloma setting. The Kyprolis plus dexamethasone arm reduced the risk of death by 21% and increased OS by 7.6 months compared to the combination of Velcade plus dexamethasone.
While Kyprolis is already approved for this patient population, the overall survival data should help drive usage and boost sales.
Other ongoing studies for Kyprolisinclude a phase III ARROW study, which is evaluating a weekly dosing regimen of Kyprolis in relapsed and refractory multiple myeloma patients and a phase III ASPIRE study evaluating a triple combination regimen of Kyprolis plus Celgene’s CELG Revlimid (lenalidomide) and dexamethasone (KRd) in patients with relapsed multiple myeloma compared to Revlimid and dexamethasone (Rd).
Amgen has also formed collaboration with J&J JNJ to study the combination of Kyprolis and J&J’s Darzalex in multiple clinical studies for the treatment of multiple myeloma.
Kyprolis generated sales of $207 million in the third quarter of 2017, recording year-over-year growth of 13% driven by higher demand and robust uptake from outside U.S. markets.
Shares of Amgen were up more than 1% on Wednesday. In the past year, Amgen’s shares have returned 22.2% compared with 3.8% increase registered by the industry.
Amgen carries a Zacks Rank #3 (Hold).
A better-ranked biotech stock is Vertex Pharmaceuticals Incorporated VRTX with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vertex’s stock has returned 90.2% in the past year while earnings estimates for 2018 have gone up by almost 2.8% in the past 30 days.
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