It's been more than three years since Amgen's ($AMGN) multiple myeloma treatment Kyprolis won approval from U.S. regulators. Now, it's finally done the same in Europe--and with competition heating up across the pond, the go-ahead couldn't have come at a better time for the California biotech.
Late last week, the European Commission (EC) green-lighted the drug in combo with Celgene's ($CELG) Revlimid and dexamethasone for treating adult multiple myeloma sufferers who have already received at least one other therapy. Regulators based the approval on data from Amgen's ASPIRE trial, which showed that patients on the cocktail recorded progression free-survival of 26.3 months, compared with 17.6 months on Revlimid and dexamethasone alone.
It's good news for Amgen, which recently picked up a new competitor in the U.S. market. Earlier this month, Johnson & Johnson ($JNJ) nabbed the FDA's favor months ahead of schedule for Darzalex--a med it priced at $135,000 per year to undercut Kyprolis' main rival, Celgene's Pomalyst.
Luckily for Amgen, Darzalex is currently only approved for patients who have received at least three prior treatments, meaning it'll come after Kyprolis in the disease course; as of July, the med bears U.S. approval for use as early as the second-line setting. But repeated courses of treatment are common in multiple myeloma, and J&J will be touting data showing that 36% of patients responded to the top dose of Darzalex in a small study, a number that tops Kyprolis' 23%.
Meanwhile, Kyprolis is still lagging behind Pomalyst when it comes to the U.S. market-share battle despite its 8-month head start. In Q3, the drug pulled in $137 million in sales, just missing Wall Street's $141 million forecast.
Kyprolis isn't the only Amgen cancer drug to pick up a European nod in the last week. On Tuesday, the EC cleared the company's Blincyto for the treatment of adults with refractory acute lymphoblastic leukemia.
- read Amgen's release
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