Recently, the Oncologic Drugs Advisory Committee of the US Food
and Drug Administration (FDA) issued a positive opinion and
recommended the US approval of
) 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
) Revlimid and low dose dexamethasone in patients suffering from
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
) are looking to expand Nexavar's label to boost the sales
potential of the drug.
We currently have a Neutral recommendation on Onyx Pharma. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.
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