Amgen Inc. (AMGN - Free Report) announced that it has submitted a supplemental new drug application (sNDA) to the FDA to get an approval for a once-weekly dosing option with respect to its multiple myeloma drug, Kyprolis, in combination with dexamethasone (Kd).
The sNDA was based on positive data from the phase III study, A.R.R.O.W.
Interim data from the trial was presented at American Society of Clinical Oncology (ASCO) meeting this year in June. The outcomes showed that treatment with the Kyprolis once-weekly regimen at a higher dose of 70 mg/m2 led to superior overall response rates (ORR) than the twice weekly regimen. The ORR in patients treated with once-weekly Kd was 62.9% compared with 40.8% in case of those treated with the twice-weekly dosage. The safety profile was comparable between the two regimens.
The FDA will review the sNDA under the Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which will expediate the review process and ensure safe and effective treatments to patients as early as possible.
Kyprolis recorded sales of $263 million during the second quarter of 2018, up 25% year over year, mostly driven by increased demand and a robust uptake in the ex U.S. markets.
Kyprolis (twice weekly) is presently approved as a monotherapy as well as in combination with dexamethasone or with Celgene Corporations’ (CELG - Free Report) Revlimid (lenalidomide) plus dexamethasone for relapsed/refractory multiple myeloma affected patients, having received one to three lines of therapy.
Notably, Amgen’s regulatory application in the United States to include the overall survival data from the ASPIRE study on the label of Kyprolis was granted an FDA approval this June. Earlier in January, the regulatory body gave a nod to Amgen’s regulatory application for inclusion of overall survival (OS) data from the head-to-head ENDEAVOR program on the label of Kyprolis.
Shares of Amgen have rallied 14.2% year to date against the industry’s decline of 4%.
Zacks Rank & Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the pharma sector include Illumina, Inc. (ILMN - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Illumina’s earnings estimates have been raised 12.1% for 2018 and 10% for 2019 over the past 60 days. The stock has soared 57.9% so far this year.
Gilead Sciences’ earnings estimates have been moved 7.5% north for 2018 and 1.9% for 2019 over the past 60 days. The stock has gained 4.4% year to date.
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