Bayer's new cancer drug Stivarga has already added a notch to its belt. Cleared by the FDA last year to treat colorectal cancer, the drug is now approved as a treatment for a rare form of gastric cancer, gastrointestinal stromal tumors.
Fast track indeed. Only three months after granting accelerated-approval status to Bayer's blockbuster hopeful regorafenib, a treatment for colorectal cancer, FDA gave the drug its final blessing.
Three months after landing FDA fast-track review status for regorafenib, Bayer 's top cancer prospect, today the agency delivered an approval as a treatment for colorectal cancer. The approval comes after a tumultuous lawsuit filed in 2009 by Onyx Pharmaceuticals ($ONXX), claiming the compound can be distinguished from Nexavar by only a single atom. Here's a look back at regorafenib's history.
Only three months after nabbing FDA fast-track review status for regorafenib, Bayer's top cancer prospect, the agency handed out a speedy approval this afternoon as a new treatment for metastatic colorectal cancer. The double-quick regulatory OK completes Bayer's quick sprint through the late-stage development process, paving the way to commercialization work expected to generate peak sales of $1.25 billion a year or more.
Onyx nailed an FDA approval today for the multiple myeloma drug Kyprolis (carfilzomib), overcoming the naysayers who were skeptical that the agency would hand out an accelerated OK for a new drug on just mid-stage data drawn from a single-arm study.
Bristol-Myers Squibb swung for the fences and whiffed, and the company's major miss provides a victory to Onyx Pharmaceuticals, the white-hot provider of Nexavar.
Bayer HealthCare and Onyx Pharmaceuticals won an inside track at the FDA today for their closely-watched cancer drug regorafenib.
Bristol-Myers presents promising PD-1 data; Genentech boasts solid T-DM1 results; GSK aces pivotal studies; Ariad's ponatinib shines; Bayer's regorafenib delays stomach cancer; Zytiga impresses in prostate cancer; Aveo makes a PhIII case for tivozanib; Seattle Genetics expands its CD-30 horizons; ADCs arrive.
Reuters reported today that Bayer is looking to close a multibillion-euro acquisition deal, quoting sources who say that an announcement could be "imminent."
Bayer has racked up a fresh set of preliminary late-stage data that will bolster its plans to market regorafenib for a range of cancers.