Pembrolizumab/Chemo Gets EU Recommendation in Resectable NSCLC
February 23rd 2024The European Medicine Agency’s Committee for Medicinal Products for Human Use’s recommendation of approving pembrolizumab plus chemotherapy in resectable non–small cell lung cancer is based on results from the KEYNOTE-671 trial.
Pembrolizumab/Chemo Receives European Approval in First-Line GI Cancers
December 18th 2023In Europe, pembrolizumab is now available as a treatment in combination with fluoropyrimidine-/platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, as well as in combination with gemcitabine/cisplatin for locally advanced biliary tract carcinoma.
Adjuvant Pembrolizumab Earns European Approval for High-Risk NSCLC
October 26th 2023Data from the phase 3 KEYNOTE-091 trial supported the European Commission’s approval of pembrolizumab as an adjuvant treatment for adults with non–small cell lung cancer at high risk of recurrence following complete resection and platinum-based chemotherapy.
Elacestrant Earns EU Approval for ESR1+, ER+, HER2– Advanced Breast Cancer
September 22nd 2023The regulatory decision to approve elacestrant in European patients with estrogen receptor–positive, HER2-negative locally advanced or metastatic breast cancer and an activating ESR1 mutation was based on data from the phase 3 EMERALD study.