Amgen Inc. (AMGN - Free Report) announced that the FDA has approved its supplemental new drug application (sNDA) for a once-weekly dosing regimen of its multiple myeloma drug, Kyprolis (carfilzomib), in combination with dexamethasone (Kd). Approval of this more convenient dosing option was based on positive data from the phase III ARROW study. Moreover, the sNDA was granted a priority review designation by the FDA.
The nod comes in just over a month from the date of filing the sNDA late in August. The FDA reviewed the sNDA under the Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which expedites the review process to ensure safe, fast and effective treatments for patients.
Past data from the ARROW study showed that treatment with the once-weekly Kyprolis regimen at a higher dose of 70 mg/m2 with dexamethasone led to superior overall response rates (ORR) and a progression-free survival (PFS) in comparison to the twice weekly regimen, administered at a lower dose of 27 mg/m2 in combination with dexamethasone. Interim data from the program was presented at American Society of Clinical Oncology (ASCO) meeting held in June this year and concurrently published in The Lancet Oncology journal.
The ORR in patients treated with once-weekly Kd70 was 62.9% compared with 40.8% in the twice-weekly dosage arm. Moreover, 7.1% of the refractory patient population achieved complete responses in the once-weekly arm as compared to 1.7% in the twice-weekly arm. The safety profile was comparable between the two regimens with no new adverse events reported.
Shares of Amgen have rallied 19.4% year to date against the industry’s decrease of 1.8%.
Kyprolis recorded sales of $485 million during the first half of 2018, mostly driven by higher demand and a robust uptake in the ex-U.S. markets.
Kyprolisis is approved as a monotherapy as well as in combination with dexamethasone or with Celgene Corporations’ (CELG - Free Report) Revlimid (lenalidomide) plus dexamethasone for the treatment of relapsed/refractory multiple myeloma in patients, who have received one to three lines of therapy.
Zacks Rank & Other Stocks to Consider
Amgen currently carries a Zacks Rank #2 (Buy). Two other top-ranked stocks in the same sector are Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Athersys, Inc. (ATHX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings estimates have been revised 28.4% upward for 2018 and 6.5% for 2019 over the past 60 days. The stock has skyrocketed 95.8% so far this year.
Athersys’ loss per share estimates has narrowed 12.5% for 2018 and 4.3% for 2019 over the past 60 days. The stock has gained 16.5% year to date.
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