Amgen is awaiting a FDA decision on Kyprolis, which currently is used as a third-line treatment for multiple myeloma.
Kyprolis generated $100 million in 2014, and is on pace to generate $500 million this year.
Multiple myeloma kills approximately 10,000 people each year in the U.S.
Amgen is on a roll with the recent approval of Repatha (evolocumab) for hypercholesterolemia---a drug which analysts think could generate $2.5 billion by 2020.
Now, this ambitious biotech is going after an expanded indication for Kyprolis for first-line treatment of refractory multiple myeloma. Based on data from a phase III study, patients whose treatment regimens included Kyprolis had an average of 18.7 months of progression-free survival---about twice as much as patients whose regimens included Velcade, the current treatment standard manufactured by Takeda and Johnson & Johnson.
Analysts suspect that Kyprolis has a good shot of gaining FDA approval for first-line treatment, because the FDA tends to look favorably upon progression-free survival data. However, the story is different in the EU, where the focus tends to be on overall survival.
Regardless, it’s been a great year for Amgen so far with two major approvals early in the year---Blincyto for acute lymphoblastic leukemia and Corlanor, which is approved for treatment of heart failure patients. After achieving $20 billion in revenues last year, Amgen is prepared to set another earnings record this year.