目的:2022 年 3 月 4 日,美国食药管理局 (FDA) 批准纳武利尤单抗联合铂类双药化疗用于可切除非小细胞肺癌 (NSCLC) 患者的新辅助治疗。本文讨论了FDA通过该批准的关键数据和监管考虑的审查。 PATIENTS AND METHODS: The approval was based on the results of CheckMate...
Immuno-Oncology at Bristol-Myers from April 2017 until October 2020, where she led the successful development of immuno-oncology assets (nivolumab and ipilimumab) from strategic planning through global submissions and approvals, including Bristol-Myers’ first FDA pilot programs (RTOR, Project ORBIS, ...
Bristol Myers Squibb Announces Phase 3 CheckMate -8HW Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Compared to Chemotherapy in Microsatellite Instability–High or Mismatch Repair Deficient Metastatic Colorectal Cancer Meets Primary.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aber...
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK ge...