Pharma Focus Asia

U.S. FDA Accepts Bristol Myers Squibb’s Supplemental Biologics Licence Application

Tuesday, February 28, 2023

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics Licence Application (sBLA) and the European Medicines Agency (EMA) has validated the Type II Variation Marketing Authorisation Application (MAA) for Opdivo® (nivolumab) as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. In the U.S., the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 13, 2023.

The applications are based on results from the Phase 3 CheckMate -76K trial, in which Opdivo demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to uniquely harness the body’s own immune system to help restore anti-tumour immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan, and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

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