Global

The Chinese National Medical Products Administration has granted conditional approval to olaparib for use as a monotherapy in the treatment in adult patients with germline or somatic BRCA-mutated, metastatic castration-resistant prostate cancer who have progressed after previous treatment that included a new hormonal agent like abiraterone acetate or enzalutamide.

Andrew Wei, MBBS, PhD

The European Commission has granted full marketing authorization to azacitidine tablets for use as a maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission or CR with incomplete blood recovery after induction therapy with or without consolidation treatment, and who are not eligible for, or do not choose to proceed to, hematopoietic stem cell transplant.

Scot W. Ebbinghaus, MD

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2-negative gastroesophageal junction adenocarcinoma with PD-L1 positivity.