FDA OKs Onyx's blockbuster Ph III cancer trial

When Onyx bought out Proteolix last year for $276 million down and up to $575 million in milestones, both sides highlighted the starring role of the cancer drug carfilzomib in the deal. Emeryville, CA-based Onyx included a $170 million payday if the drug gets an accelerated approval. And the developer sees the therapy as a likely blockbuster able to earn the kind of big bucks that Nexavar is racking up.

Today, Onyx saw its share price buoyed by its announcement that the FDA had signed off on a key late-stage trial of the blood cancer therapy. The pivotal trial is expected to get underway in the first half of the year. The Phase III is designed to "evaluate the efficacy of carfilzomib in combination with lenalidomide and low dose dexamethasone, versus lenalidomide and low dose dexamethasone alone," says the company in a release.

"The SPA enables us to initiate this carfilzomib Phase III combination trial in the first half of this year with increased clarity on the full approval pathway," says Michael Kauffman, M.D., Ph.D., chief medical officer at Onyx. "In the Phase IIb data (from the "006" trial) reported at the American Society of Hematology meeting last December, carfilzomib showed promising response rates and good tolerability with this three-drug combination in patients with relapsed or refractory myeloma."

- here's the press release
- check out the AP report

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