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Priority Review from Denosumab for Bone Metastases, Orphan Drug Status from BiovaxID, Approval of Generic Enoxaparin

doi: 10.1097/01.COT.0000388584.07467.25

The FDA has granted priority review to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal-related events in cancer patients.

The application was based on a compilation of experience with approximately 6,900 patients across 18 clinical studies, including about 5,700 patients with advanced cancer in the three pivotal Phase III head-to-head trials versus zoledronic acid.

The FDA Priority Review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.

Consistent with priority review guidelines, the FDA will target an Agency action within six months of the application's submission date, meaning that the expectation is that the Prescription Drug User Fee Act (PDUFA) action date would be November 18 of this year.

In other recent FDA actions related to cancer, Orphan Drug designation was given to BiovaxID personalized cancer vaccine for mantle cell lymphoma. The vaccine had previously received the designation for indolent follicular non-Hodgkin's lymphoma.

The Agency also approved the fi rst generic version of Lovenox (enoxaparin), an anti-coagulant drug used for multiple indications, including the prevention of deep vein thrombosis.

Prior to the approval, the FDA received a citizen petition questioning the approval criteria for generic enoxaparin sodium injection, and after careful review of the petition, the agency determined that current scientific evidence, precedent, and the FDA's legal authority establish a basis for the approval of the generic drug.

Manufacturing of generic enoxaparin sodium injection has been granted to Sandoz Inc., and has been approved in strengths of 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL, 120 mg/0.8 mL, and 150 mg/mL.

The prescribing information for both Lovenox and its generic version includes a boxed warning that use of the drug in patients undergoing spinal/epidural anesthesia or spinal puncture increases the risk of spinal or epidural bleeding and bruising, which may cause long-term or permanent paralysis.

© 2010 Lippincott Williams & Wilkins, Inc.
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