Stable Cancer Patients Phase I Dosing Could Be Extended If Benefit Shown
Executive Summary
A Phase I trial participant should be allowed to continue receiving an investigational oncology compound beyond the duration of animal safety data if he has stable disease and he and his physician agree that this represents a benefit from therapy, FDA's Oncologic Drugs Advisory Committee said March 13
You may also be interested in...
Bayer/Onyx Nexavar Approved For Broad Advanced Kidney Cancer Indication
FDA's full approval of Bayer/Onyx' kidney cancer therapy Nexavar (sorafenib) covers both refractory and first-line use
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials