Bayer and Onyx’s Cancer Drug Approved by FDA

Bayer and Onyx Pharmaceuticals have announced that US regulators have approved Stivarga for the treatment of metastatic colorectal cancer.

Yesterday, the Food and Drug Administration (FDA) approved Stivarga (regorafenib) for the medication of patients with mCRC who have been previously been treated with currently available therapies.

The green light for the oral multi-kinase inhibitor is founded on results from a Phase III clinical study that demonstrated a statistically significant improvement in overall survival (6.4 months versus 5.0) and progression-free survival (2.0 months versus 1.7), in comparison to placebo, in patients with mCRC whose disease had advanced after approved standard therapies.

There are a number of colorectal cancer drugs presently on the market, including Roche’s Avastin, Eli Lilly/Merck KGaA/Bristol-Myers Squibb’s Erbitux and Amgen’s Vectibix.  Just last month, the FDA approved Sanofi/Regeneron’s ziv-aflibercept injection in combination with FOLFIRI (5-fluorouracil, leucovorin and irinotecan) chemotherapy.

Stivarga’s approval, which came one month ahead of its Prescription Drug User Fee Act goal date, “is an important milestone for Bayer as it marks the first approval of this innovative cancer treatment to fulfill a significant unmet medical need,” commented Joerg Reinhardt, the organisation’s healthcare chief.  The drug will carry a boxed caution noting that severe and fatal liver toxicity occurred in patients treated with Stivarga during clinical studies.

The Food and Drug Administration noted that colorectal cancer is the third-most common cancer in America, and is the third leading cause of cancer death.  They added that around 143,460 cases are expected to be diagnosed in 2012, and about 51,690 people will die of the disease.

Last month, regorafenib was also submitted in the US for gastrointestinal stromal tumours.  The drug was at the centre of a disagreement between Bayer and Onyx which was settled in October 2011.  In May 2009, Onyx sued over the rights to the drug, claiming it is a variant of the two firms’ liver and kidney cancer drug Nexavar (sorafenib), while Bayer always insisted that regorafenib is not covered by a collaboration the companies signed in 1994.

The settlement recognised that regorafenib is a Bayer compound, while Onyx will receive a 20% royalty.  The US biotech will not have to pay any development and commercialisation costs and the two companies will co-promote Stivarga.


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