Amgen ($AMGN), which has been looking to steal market share from Celgene's ($CELG) Pomalyst in treating multiple myeloma, has won a new FDA approval for Kyprolis that will help it in that fight.
The FDA granted approval Friday for Kyprolis in combination with Revlimid and dexamethasone (KRd) for the treatment of relapsed multiple myeloma. The approval was based on results from the ASPIRE trial, which found that in addition to extending progression-free survival to 26.3 months from 17.6 months, adding Kyprolis to a combo of Celgene's Revlimid plus the chemo drug dexamethasone upped overall response rate to 87% from 67%.
|Amgen's Sean Harper|
"The approval of a second indication for Kyprolis in just three years demonstrates that it is becoming a critical component in the treatment of multiple myeloma, and underscores our commitment to advancing care for patients with this challenging disease," Sean Harper, R&D chief for the Thousand Oaks, CA-based company, said in a statement.
This could represent a turning point for the drug, which Amgen got in 2013 in its out $10.4 billion buyout of Onyx Pharmaceuticals, a deal done primarily on Kyprolis' upside potential. Analysts have estimated peak sales at $1.6 billion. It turned in only $331 million in sales for 2014 but has been building some momentum this year. It sold $108 million in Q1, up 59% from the year-ago quarter. But Celgene has seen its sales of Pomalyst grow as well, hitting $235 million in Q2 report, up 46%.
The company is looking to eventually bag a first-line nod, which would open access to larger patient pools and lengthen the duration of therapy.
The drug is also awaiting approval in Europe and Amgen has hoped the ASPIRE results will help it there. A year ago, the company announced Kyprolis had missed its primary endpoint in the Phase III FOCUS trial, failing to extend survival compared with standard care, which analysts thought could hurt its chances with the EU. It has added the ASPIRE results to the data submitted to the EU.
- here's the Amgen release
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