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Further Winter 2010 FDA Updates
The FDA has pushed back the deadline for issuing a final ruling on the Biologic Licensing Application that Bristol-Myers Squibb (BMS) submitted for its promising advanced melanoma drug ipilimumab. The agency had agreed to give the novel drug a priority review, and a decision had been expected by December 25, 2010. The agency subsequently asked BMS for additional information and further analysis of the data. BMS promptly complied with this request, but the FDA said the new information resulted in a “major amendment” to the BLA. It now expects to announce its decision on March 26, 2011.
Sprycel (dasatinib) has become the third tyrosine kinase inhibitor approved by the FDA as a first-line treatment for patients with newly diagnosed Philadelphia chromosome–positive (Ph ) chronic myeloid leukemia (CML) in the chronic phase. It joins Gleevec (imatinib), the first targeted agent approved for this indication, and its offspring Tasigna (nilotinib). Unlike Gleevec and Tasigna, which primarily inhibit the BCR-ABL protein associated with Ph CML, platelet-derived growth factor receptor, and KIT, Sprycel inhibits BCR-ABL and Src. The FDA granted accelerated approval to Sprycel in 2006 as a second-line therapy in patients who were resistant to or intolerant of imatinib. None of these approved agents is effective in patients with CML who have the T135I mutation.
Earlier this year, the FDA launched an investigation into whether the gonadotropin-releasing hormone (GnRH) agonists used to treat advanced prostate cancer contributed to an increased patient risk of diabetes and cardiovascular disease. The agency reviewed several studies that had suggested a possible relationship between GnRHs and these conditions. In October, the FDA announced that although the risk was small, it was statistically significant. Now, the agency wants GnRH manufacturers to add new safety information to their labels that warn physicians and patients of the risks. Products subject to the ruling include leuprolide acetate (Eligard, Lupron, Lupron Depot, Viadur); goserelin acetate (Zoladex); triptorelin pamoate (Trelstar); and histrelin acetate (Vantas).
The FDA has announced that it intends to reclassify digital mammography systems approved in the United States as Class II devices. Currently, the systems are designated Class III devices. It is anticipated that this change will make it easy for manufacturers of these screening and diagnostic devices to get approval. Class II devices are associated with medium risk to patients and are considered safer than Class III devices. The FDA said it had several discussions with the public and medical experts and was reassured that evidence shows the technology is safe for screening and diagnosing breast cancer.
The FDA reported that it has granted orphan drug status to ensituximab (NPC-1C), an investigational drug being developed by Neogenix Oncology as a therapy for pancreatic cancer. Ensituximab is a chimeric monoclonal antibody. Neogenix is investigating the novel agent in a phase I clinical trial for patients with previously treated advanced pancreatic cancer and colorectal cancer. The company has received two federal grants to help fund its research into ensituximab under the Patient Affordability Care Act. Orphan Drug Status is designed to make it easier for companies to develop new drugs for rare conditions affecting <200,000 Americans.
The mTOR inhibitor Afinitor (everolimus), marketed by Novartis Pharmaceuticals, has been given accelerated approval by the FDA to treat nonresectable subependymal giant cell astrocytoma (SEGA). These benign tumors are associated with tuberous sclerosis, a rare genetic disorder that occurs more frequently in children and adolescents. The oral drug was approved to treat SEGAs after a single-arm study showed that 32% of patients with SEGA experienced a ≥50% reduction in tumor volume after 6 months of therapy and none developed a new SEGA after a median of 2 years of therapy with Afinitor. Complete findings appear in the November 3 issue of the New England Journal of Medicine.
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