FDA: Thumbs Up for Onyx Drug

Recently, the Oncologic Drugs Advisory Committee of the US Food and Drug Administration (FDA) issued a positive opinion and recommended the US approval of Onyx Pharmaceutical’s ( ONXX - Analyst Report ) oncology candidate Kyprolis (carfilzomib).

The panel recommended the clearance of the candidate in the US for treating patients with relapsed and refractory multiple myeloma (MM), who have received at least two prior therapies. A final decision from the FDA regarding the matter is expected by July 27, 2012 (target date). Although the FDA is not bound to accept the recommendation of the advisory committee, it usually does so.

The FDA’s advisory panel met to review the new drug application (NDA) submitted by Onyx Pharma primarily on the basis of data from a phase IIb study (003-A1: n=266). While reviewing the application, the panel voted overwhelmingly (11-0) in favor of clearing Kyprolis in the US. One panel member abstained from voting.

We note that Onyx Pharma is also evaluating Kyprolis in a phase III study (ASPIRE) in combination with Celgene Corporation’s ( CELG - Analyst Report ) Revlimid and low dose dexamethasone in patients suffering from relapsed MM.

We note that Onyx Pharma is banking heavily on the approval of Kyprolis as currently it just has one marketed product, Nexavar, in its portfolio. Nexavar is currently marketed worldwide as a treatment for unresectable liver cancer and advanced kidney cancer. We note that Onyx Pharma and partner Bayer ( BAYRY - Analyst Report ) are looking to expand Nexavar’s label to boost the sales potential of the drug.

Our Recommendation

We currently have a Neutral recommendation on Onyx Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short run.