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Bristol-Myers Squibb's blockbuster immunotherapy combination receives FDA priority review

 Last Update: 2022-05-23
 Source: Internet
 Author: User

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Bristol-Myers Squibb (BMS) announced today that the U.

Lung cancer is the leading cause of cancer death worldwide

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses

The application is based on the results of the pivotal Phase 3 clinical trial CheckMate-816, in which Opdivo in combination with chemotherapy, when administered preoperatively, demonstrated a pathological complete response (meaning that in surgically resected tissue or There was a statistically significant and clinically meaningful improvement in tissue biopsy samples without any sign of cancer, pCR) and event-free survival (EFS)

References:

[1] US Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb's Application for Opdivo (nivolumab) Plus Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer.

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