EU’s CHMP Recommends Nivolumab/Chemo for Approval in Resectable NSCLC
May 31st 2023Data from the phase 3 CheckMate 816 trial support the European Medicines Agency’s Committee for Medicinal Products for Human Use recommendation to approve nivolumab plus platinum-based chemotherapy as a treatment for resectable non–small cell lung cancer.
Durvalumab/Tremelimumab Approved in Japan for Advanced NSCLC and Select Unresectable GI Cancers
January 4th 2023The decision to approve durvalumab plus tremelimumab in Japan for patients with advanced non–small cell lung cancer and unresectable biliary tract cancer and liver cancer was based on data from several phase 3 studies.
European Commission Approves 177Lu Vipivotide Tetraxetan Plus ADT for Prostate Cancer Subset
December 17th 2022177Lu vipivotide tetraxetan becomes first targeted radioligand treatment approved by the European Commission for prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.
European Commission Approves Cemiplimab for Recurrent/Metastatic Cervical Cancer
November 23rd 2022The European Commission’s approval of cemiplimab for recurrent or metastatic cervical cancer marks the first second-line immunotherapy option available for this patient population regardless of tumor histology.