Amgen's Kyprolis wins 'backbone therapy' FDA nod after trumping Velcade in trial

Back in March, Amgen's ($AMGN) Kyprolis posted impressive results in a head-to-head trial with Takeda behemoth Velcade--and now, those results have helped it grab an important thumbs up from the FDA.

Thursday, the agency approved the med in tandem with dexamethasone or with dexamethasone plus Celgene's ($CELG) Revlimid to treat patients with relapsed or refractory multiple myeloma who have already received between one and three other treatments, the company said. Separately, U.S. regulators green-lighted the med on its own to treat patients with relapsed or refractory forms of the disease who have received one or more lines of therapy--effectively converting a 2012 accelerated approval for the med into a full approval.

The combo go-ahead "supports the use of Kyprolis as a backbone therapy" for the management of the disease, Amgen R&D Chief Sean Harper said in a statement, and it's one that comes based on progression-free survival data that showed Kyprolis could stave off myeloma for twice as long as Velcade.

The approval could make a significant impact for the California biotech, which shelled out nearly $10 billion for Kyprolis' maker, Onyx Pharmaceuticals, back in 2013. As Evercore ISI analyst Mark Schoenebaum wrote in a March note to investors, $1.6 billion peak sales estimates would potentially have to go up, and investors' opinion of the Onyx deal would probably improve, too. Thus far, the med hadn't quite put up the performance they'd hoped for, posting $137 million in Q3 sales that missed the Street's prediction of $141 million.

Of course, the ultimate goal for Amgen is to snag a first-line indication for Kyprolis, which would open access to larger patient pools and lengthen the duration of therapy. And the March head-to-head results vs. Velcade indicated that a trial pitting the two against one another in newly diagnosed myeloma patients could succeed, too, Schoenebaum said at the time.  

- read Amgen's release

Special Reports: The top 15 pharma companies by 2014 revenue - Amgen | Top 20 orphan drugs by 2018 - Kyprolis | Pharma's top 10 M&A deals of 2013 - Amgen/Onyx

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