Bayer/Onyx will wait for kidney oncologic Phase III data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bayer/Onyx plan to wait for Phase III overall survival results for their kidney cancer agent BAY 43-9006 instead of moving forward with submission using Phase II data, which will push launch projections back to 2006. Bayer outlined a plan to file based on the Phase II results when the data was presented at the American Society of Clinical Oncology meeting in June. The firms expect to enroll 800 renal cell carcinoma patients in the Phase III trial of the RAF kinase inhibitor, now underway. The trial "was initiated after a special protocol assessment was completed by the FDA in the fourth quarter of 2003," Onyx says Oct. 25...
You may also be interested in...
Bayer/Onyx BAY 43-9006 Interim Analysis To Support Accelerated NDA Filing
Onyx expects its kidney cancer therapy BAY 43-9006 to receive accelerated approval by 2006 based on initial Phase III data showing statistically significantly longer progression-free survival versus placebo
Bayer/Onyx 43-9006 in Phase III for HCC
Bayer/Onyx are starting a Phase III study of their oral RAF kinase/VEGF inhibitor 43-9006 (sorafenib) for use as monotherapy in advanced hepatocellular carcinoma, the firms say March 8. Five hundred patients without prior systemic treatment will be randomized in the double-blind, placebo-controlled trial; overall survival, time to symptom progression and time to tumor progression will be assessed. Median survival was 9.2 months and median time to progression was 4.2 months in a Phase II HCC trial. Bayer/Onyx originally planned to submit 43-9006 for renal cell carcinoma based on Phase II data, but are now waiting for results from an 800-patient Phase III study (1Pharmaceutical Approvals Monthly November 2004, p. 35). Both Phase III trials received special protocol assessments from FDA...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.