Eli Lilly Scraps Late-Stage Head and Neck Cancer Drug: Biotech's Latest Tribulations
The Burrill Report submits: Eli Lilly (LLY) said that its global phase 3 trial evaluating Alimta (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck failed to meet its primary endpoint for overall survival. Data were presented for the first time at the 35th Annual Meeting of the European Society for Medical Oncology. The phase 3 study, the largest trial conducted in squamous cell cancer of the head and neck to date, evaluated Alimta in combination with cisplatin compared with placebo plus cisplatin given every three weeks in a total of 795 patients. The primary objective of the study was to determine overall survival. The Alimta/cisplatin regimen showed a median overall survival of 7.3 months compared with 6.3 months with cisplatin alone, a result not considered a statistically significant improvement. As a result, Lilly said it will not be submitting marketing authorization applications for Alimta in squamous cell cancer of the head and neck with either the U.S. Food and Drug Administration or the European Medicines Agency. The U.S. Food and Drug Administration notified Alexza Pharmaceuticals (ALXA) that it would not approve AZ-004, which is being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. Valeant Pharmaceutical's (VRX) subsidiary, Biovail Laboratories International (BVF), entered into a collaboration and license agreement with Alexza in February 2010 for the U.S. and Canadian rights to commercialize AZ-004. The agency said that its primary clinical safety concern was related to data from three phase 1 pulmonary safety studies with AZ-004. Alexza intends to meet with the FDA in the near future to discuss steps necessary to address this FDA concern. The agency also raised issues relating to the suitability of the stability studies undertaken by Alexza and certain other items relating to the FDA's recently completed pre-approval manufacturing inspection. Because AZ-004 incorporates a novel delivery system, the FDA also included input from its Center for Devices and Radiological Health. CDRH requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting. CDRH also requested further bench testing of the product under an additional “worst-case” manufacturing scenario. Complete Story »
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