Bayer Healthcare, Onxy Pharma gets USFDA OK for Stivarga tablets

Bayer HealthCare and Onyx Pharmaceuticals Inc said that U.S. Food and Drug Administration has approved Bayer’s Stivarga ® (regorafenib) tablets to treat patients with metastatic colorectal cancer.

The approval for Bayer’s Stivarga tablets is based on the results from the Phase III study which demonstrates improvement in the overall survival and progression-free survival.

Stivarga is a Bayer compound developed by Bayer, the company said. Last year, Bayer signed a deal with Onyx Pharmaceuticals, Inc under which Onyx will get a royalty on any future global net sales of Stivarga in oncology. 

Both these companies will jointly promote Stivarga in the United States. “The approval of Stivarga reflects Bayer’s commitment to confronting the challenges of difficult-to-treat cancers,” said, Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  “Patients with metastatic colorectal cancer whose disease has returned after treatment will now have a new option that has been shown to prolong survival and keep the cancer from progressing.," Pamela said.

Stivarga is indicated to treat patients with mCRC  who have been earlier treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

The frequently observed adverse drug reactions in patients receiving Stivarga are asthenia, decreased appetite and food intake, hand-foot-skin reaction, erthrodysesthesia, diarrhea, mucositis, weight loss, infection, hypertension and dysphonia.  

Most serious adverse drug reaction in patients receiving Stivarga includes hepatotoxicity, hemorrhage and gastrointestinal perforation.

Bayer HealthCare is the U.S.-based pharmaceuticals business of Bayer Healthcare LLC, a subsidiary of Bayer AG. It is also the world’s innovative companies in the healthcare and medical products industry.