Regeneron Pharmaceuticals (NSDQ:REGN) and Sanofi (NSDQ:SNY) have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer. A press release noted that the agency and the sponsors were unable to “align on certain post-marketing studies” that would have been required to greelight the sBLA. FDA first…
FDA grants Enhertu priority review for HER2-positive positive metastatic breast cancer
FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY). The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen. FDA also granted priority review to the…