Celgene's development plan for Revlimid has run into a brick wall of bad data. The biotech ($CELG) halted a late-stage study of the blockbuster drug for castration-resistant prostate cancer after an independent group of trial overseers came to the conclusion that a combo of Revlimid with the standard therapy would not demonstrate an improvement in overall survival--the gold standard for cancer drugs.
Revlimid earned $2.47 billion last year, largely for multiple myeloma, and Celgene had been hoping to add prostate cancer to the list of diseases that it could be used for. The Mainsail study had combined Revlimid with the chemotherapy drug docetaxel and the steroid prednisone, comparing the data with a separate arm receiving the docetaxel/prednisone combination.
"We have accepted this recommendation of the DMC and following formal notification and review of the analysis, physicians and patients, internationally, will be officially advised of this action," Celgene noted in a release.
While certainly disappointing for Celgene, which saw a big upside on the prostate cancer side even as new therapies have come into the marketplace, analysts expect to see Revlimid continue to rake in growing sums in coming years. Celgene also has a number of cancer trials under way for its recently acquired Abraxane. The developer also has a slate of stem cell studies under way with an eye to nailing its first approval around 2015.
- read the press release
- here's the Reuters story
Special Report: Celgene - Biotech's Biggest Spenders 2011