Roche obtains FDA Approval for Cobas KRAS Mutation Test


Roche announced Monday that the U.S. Food and Drug Administration has approved the cobas KRAS Mutation Test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer or mCRC patients and aid clinicians in determining a therapeutic path for them.
According to the Centers for Disease Control and Prevention, colorectal cancer is the second leading cause of cancer-related deaths in the United States and the third most common cancer in men and women. The cobas KRAS Mutation Test is intended to be used as an aid in the identification of mCRC patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) may be effective if no KRAS mutation is present.
In a separate press release, Genentech, a member of the Roche Group, said that it will present data from 10 of its approved cancer medicines and 10 investigational medicines during the American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2 in Chicago.
These data demonstrate the strength of Genentech's oncology pipeline, particularly in cancer immunotherapy and personalized medicine. Updated results from studies of cobimetinib in combination with Zelboraf (vemurafenib) will also be presented at ASCO.
Cobimetinib is currently under review with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Data presented at ASCO for alectinib and Gazyvawill support regulatory submissions, and the Gazyva data will be highlighted as part of ASCO's official press program.
Genentech noted that it is also discussing interim data for MPDL3280A from the POPLAR study with the FDA as part of its Breakthrough Therapy Designation in lung cancer.
Preliminary data will also be presented on investigational medicine venetoclax in NHL and multiple myeloma. The FDA recently granted Breakthrough Therapy Designation to venetoclax for people with relapsed/refractory chronic lymphocytic leukemia who have a genetic abnormality known as 17p deletion.