CHMP backs Stivarga, Provenge
EMA's CHMP backed a number of cancer compounds on Friday, including Stivarga regorafenib from Bayer AG (Xetra:BAYN) and Provenge sipuleucel-T from Dendreon Corp. (NASDAQ:DNDN). Stivarga is recommended to treat metastatic colorectal cancer (mCRC) in adults who have been previously treated with or who are not considered candidates for available therapies. The dual acting signal transduction (DAST) inhibitor of multiple kinases is already approved in the U.S. to treat mCRC and locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST), and in Japan to treat unresectable, advanced or recurrent colorectal cancer.
The committee also backed Provenge for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC) in adults when chemotherapy is not yet clinically indicated. Dendreon markets Provenge in the U.S. to treat metastatic CRPC in patients who are asymptomatic or minimally symptomatic. The product is autologous dendritic cells loaded with a fusion protein of prostatic acid phosphatase and an immunostimulatory cytokine. On Friday, Dendreon was up $0.04 to $4.12. ...