Oncology Drugs Pending FDA Approval in 2012
Roche’s vismodegib has received Priority Review status, with a confirmed action date of March 8, 2012. It is aimed at the treatment of advanced basal cell carcinoma (BCC). Vismodegib is an oral medicine designed to selectively reduce signaling in the Hedgehog pathway, which is associated with more than 90% of BCC cases.
According to Onyx Pharmaceuticals, Inc., the FDA recently accepted the New Drug Application (NDA) submission for carfilzomib, a next-generation proteasome inhibitor aimed at patients with relapsed and refractory multiple myeloma.
Ted Love, MD, executive vice president, research and development and technical operations at Onyx Pharmaceuticals, says, “...we look forward to hearing back from the FDA in the next few weeks regarding priority versus standard review.”
A NDA has been resubmitted to the FDA Division of Oncology Drug Products by Cell Therapeutics, Inc. (CTI) for accelerated approval of pixantrone, a drug to treat relapsed or refractory aggressive non-Hodgkin lymphoma.
“We believe the resubmitted NDA not only addresses the items in the Complete Response Letter, but confirms the reliability of the initial efficacy results, which we believe demonstrate that pixantrone does provide a clinical benefit to this patient population for which there are no currently approved therapies,” said James A. Bianco, MD, CEO of CTI. An action date is estimated for April 2012.
Based on results from a recent study, Amgen filed to expand the indication for Xgeva to include reducing the risk of developing bone metastases in men with nonmetastatic castration-resistant prostate cancer. The FDA’s targeted action date is April 26, 2012. If approved, Xgeva will be the only therapy authorized for the prevention or delay in the spread of cancer to the bone.
Sources: Roche; Onyx Pharmaceuticals; Cell Therapeutics; Amgen.
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