There’s been a flurry of activity in recent weeks when it comes to oncology drug filings at the FDA. While every application is unique, the agency is required to decide within 60 days whether a new drug application (NDA) will move forward for a full review.
The FDA’s Center for Drug Evaluation and Research seeks to review an NDA within 10 months at the latest and within 6 months for those applications granted priority status, according to agency policies.
Here are 5 drugs that have advanced through the clinical trials process to FDA filings since mid-December.1 Promising Prostate Cancer Drug Under Review
Abiraterone acetate, which has generated much excitement in research circles as a treatment for metastatic advanced prostate cancer, was submitted for review under an NDA filing in December. The drug is an oral androgen believed to inhibit the key enzyme CYP17. Centocor Ortho Biotech Inc, Horsham, Pennsylvania, is seeking approval to market the drug for patients with castrate-resistant prostate cancer who have received prior chemotherapy containing a taxane.2 Lung Cancer Therapy Gets Rolling
The NDA for crizotinib (PF-02341066), a first-in-class treatment for patients with advanced non-small cell lung cancer (NSCLC), is being submitted on a rolling basis after the FDA granted the drug fast-track status in December, said Pfizer Inc. The company, headquartered in New York City, anticipates completing the submission by July. Crizotinib, an oral compound, is an anaplastic lymphoma kinase (ALK) inhibitor for NSCLC patients whose tumors are ALK-positive.3 New Step for Blood Cancer Treatment
Carfilzomib, a next-generation proteasome inhibitor, will be evaluated for approval under the fast-track designation for the treatment of patients with relapsed and refractory multiple myeloma. Onyx Pharmaceuticals, Inc plans to complete its NDA submission on a rolling basis by midyear. The Emeryville, California, company is developing carfilzomib under the orphan drug program. The drug also is being investigated as a first-line multiple myeloma treatment as well as in lymphoma and other cancers.4 Approval Sought for New Vinorelbine Formulation
Exelbine (ANX-530) is under review as a novel emulsion formulation of the chemotherapy drug vinorelbine for the treatment of non-small cell lung cancer. Adventrx Pharmaceuticals, Inc said its formulation is aimed at reducing the incidence and severity of injection-site reactions patients experience with Navelbine, which has been approved since 1994, and its generic equivalents. The San Diego, California, company announced the NDA filing in January and expects the FDA to complete its review by September 1.5 Leukemia Drug on Fast Track
A Norwegian drug development company is recruiting patients for a clinical trial of elacytarabine, a novel lipid-conjugated form of cytarabine for the treatment of patients with acute myeloid leukemia (AML), after the drug was granted fast-track status in December. Clavis Pharma, based in Oslo, said clinical trial results are expected during the second half of 2012, with regulatory filings to follow if findings are positive. Elacytarabine has been designated as an orphan drug by the FDA and the European Medicines Agency, the company said.First Diagnostic Radiology App Approved
Physicians will be able to make a diagnosis based on what they see on their iPhone or iPad now that the FDA has given its seal of approval to a mobile radiology application for the first time. Mobile MIM, created by MIM Software Inc, enables physicians to analyze radiology images created in a hospital or office and transferred via a secure network to a portable wireless device.
The FDA said various devices were tested for luminance, image resolution, and noise before the Apple product was chosen. One important Apple feature is an interactive contrast test that allows the user to check the screen so the lighting conditions do not interfere with the ability to see subtle differences in images.
The FDA cleared the application for viewing images from computed tomography, magnetic resonance imaging, and nuclear medicine technology such as positron emission tomography. The agency said it is indicated for use when physicians are not able to access a workstation. For more information, visit http://tiny.cc/hz8f3
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