Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the US Food and Drug Administration (FDA) confirmed in a new guidance document released this week. The final guidance document, Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics , is intended to clarify the evidence FDA is willing to accept in the review of new NSCLC d...

A new final guidance document issued by the US Food and Drug Administration (FDA) outlines the processes by which the regulator will accept surrogate endpoints to support the accelerated approval of treatments intended for high-risk early-stage breast cancer. Background Under normal circumstances, FDA requires "substantial evidence"—generally two Phase III clinical trials—indicating that a product is safe and effective at treating, preventing or curing a given condition...

The US Food and Drug Administration (FDA) has announced a four-day meeting to discuss clinical endpoints potentially capable of being used to support future drug development in four therapeutic areas. The 19-24 September workshop, entitled " Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) ," is intended to discuss issues related to endpoints for eosinophilic esophagitis, pediatric and adult inflammatory bowel disease (IBD) and parenteral...

Jakafi® (ruxolitinib) was approved 1 by the US Food and Drug Administration (FDA) on 16 November 2011 for the treatment of intermediate or high-risk myelofibrosis (MF) including primary MF, post-polycythemia vera MF (PPV-MF) and post-essential thrombocythemia MF (PET-MF). Prior to this time, there were no approved products, and therefore no precedent for regulatory endpoints in this orphan disease. MF is a highly symptomatic 2 myeloproliferative neoplasm (MPN), cha...