Abraxane Lung Cancer Approval Comes With Questionable Commercial Value
This article was originally published in The Pink Sheet Daily
FDA clears Celgene’s Abraxane in lung cancer despite its lack of even a progression-free survival benefit. But the ease of approval is reassurance ahead of the release of melanoma results, with a PFS benefit, in November.
You may also be interested in...
Abraxane more than doubled two-year survival and conferred a near-two-month overall survival advantage against pancreatic cancer compared with standard of care gemcitabine alone in the Phase III MPACT trial, presented Jan. 25 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco. Celgene plans global regulatory filings by mid-2013.
Celgene reported strong sales for key products, led by Revlimid, during its year-end 2012 call. The biopharma affirmed 2013 guidance, detailing the key regulatory and commercial drivers that will power the global expansion of its hematology, oncology, and immunology franchises. In particular, it highlighted the commercial potential for apremilast.
Celgene CEO Bob Hugin gave investors a taste of what’s to come for the biotech as it prepares for multiple NDA filings this year and the influx of data on several new indications for its lead drugs.