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…
Pfizer-BioNTech COVID-19 vaccine 100% effective in adolescents 12 to 15
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose. The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In…
FDA accepts priority review for BMS’s relatlimab and nivolumab in melanoma
Bristol Myers Squibb (NYSE: BMY) has won priority review for its Biologics License Application for the fixed-dose combination of the checkpoint inhibitors relatlimab and nivolumab to treat patients 12 and older who weigh at least 40 kg (88 pounds) with unresectable or metastatic melanoma. Relatlimab would be a novel lymphocyte-activation gene 3 (LAG-3) blocking antibody.…