FDA Offers Possible Reasons For Vectibix Failure To Show Survival Benefit
This article was originally published in Pharmaceutical Approvals Monthly
FDA review documents for Amgen's epidermal growth factor receptor inhibitor Vectibix (panitumumab) outline possible factors that may have led to the biologic's failure to show an overall survival benefit in a pivotal trial.
You may also be interested in...
For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.
Genentech Avastin lung cancer claim clears FDA, while Merck’s new molecular entity Zolinza (vorinostat) is approved for cutaneous T-cell lymphoma. Schering-Plough’s novel antifungal Noxafil (posaconazole) is the first treatment cleared for prevention of invasive Aspergillus infection. Genentech/Biogen Idec’s Rituxan (rituximab) gains a third NHL-related claim with approval of two new indications; Johnson & Johnson’s established anti-TNF agent Remicade (infliximab) expands into the dermatology segment with approval for psoriasis. More approvals in brief
Seeing a gap between the large infrastructure being built in China by multinational and domestic companies, Ascendancy hopes to be an interface to help China access drugs from the West.