Approval based on results from Phase 3 CheckMate -816 trial showing that neoadjuvant Opdivo with chemotherapy improved event-free survival and pathologic complete response compared to chemotherapy alone
Opdivo with chemotherapy is now the first and only neoadjuvant immunotherapy-based treatment option approved to treat patients with non-small cell lung cancer in the European Union
This decision marks the fourth tumor type in which Opdivo-based regimens have been approved for use in earlier stages of cancer in the European Union, following melanoma, esophageal/gastroesophageal junction cancer and urothelial carcinoma
Amivantamab elicited an objective response rate of 37% per investigator assessment, with a median duration of response of 12.5 months, according to long-term data from the CHRYSALIS trial.
Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion Recommending Approval for Opdivo with Chemotherapy streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
Recommendation based on results from the Phase 3 CheckMate -816 trial, in which Opdivo with chemotherapy demonstrated improved event-free survival and pathologic complete response compared to. | May 26, 2023