The FDA on Thursday approved belzutifan, sold as Welireg, in combination with lenvatinib, sold as Lenvima, for adults with advanced clear cell kidney cancer that has progressed after immunotherapy, according to the agency's approval announcement. Both drugs are taken by mouth once a day. In the trial behind the approval, the pairing kept cancer from growing for longer than a standard pill treatment.
The approval comes with a notable limit. The FDA said the final analysis of overall survival was not statistically significant. Patients on the combination lived longer on average, but researchers could not rule out that the difference happened by chance.
