NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
No Result
View All Result
Home ALL Healthcare

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma

by Ed Johnson
September 21, 2021
A A

The application is based on Phase 2/3 RELATIVITY-047 trial, in which the relatlimab and nivolumab fixed-dose combination demonstrated a statistically significant and clinically meaningful progression-free survival benefit over Opdivo monotherapy

U.S. Food and Drug Administration assigns a target action date of March 19, 2022

PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

“Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there continue to be patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. “Based on the results of the RELATIVITY-047 trial, we believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metastatic or unresectable melanoma. We look forward to potentially introducing the first LAG-3-blocking antibody, and Bristol Myers Squibb’s third distinct checkpoint inhibitor, to help patients in need.”

The BLA submission was based on the efficacy and safety results of the Phase 2/3 RELATIVITY-047 trial, which demonstrated a statistically significant and clinically meaningful progression-free survival benefit of a combination therapy over standard of care anti-PD-1 monotherapy in metastatic melanoma. Relatlimab is the first LAG-3-blocking antibody to demonstrate a clinical benefit for patients with Phase 3 data. Primary results from the RELATIVITY-047 trial were presented in an oral session during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021 and were selected for the official ASCO press program.

The fixed-dose combination of relatlimab and nivolumab is an investigational therapy and is not approved for use in any country.

Bristol Myers Squibb thanks the patients and investigators involved in the RELATIVITY-047 clinical trial.

Tags: < New Launches
ShareTweetShareSend

Related Industries

Healthcare

Medtronic recommends rejection of below-market mini-tender offer by TRC Capital Investment Corporation

January 26, 2023
Healthcare

Johnson & Johnson Reports Q4 and Full-Year 2022 Results

January 25, 2023
Healthcare

Pfizer Expands ‘An Accord for a Healthier World’ Product Offering to Include Full Portfolio for Greater Benefit to 1.2 Billion People in 45 Lower-Income Countries

January 18, 2023
Healthcare

AbbVie and Anima Biotech Announce Collaboration for the Discovery and Development of mRNA Biology Modulators against Oncology and Immunology Targets

January 11, 2023
Healthcare

Baxter Announces Strategic Actions to Enhance Operational Effectiveness, Accelerate Innovation for Patients and Drive Value for Shareholders

January 7, 2023
Healthcare

Michelle Quinn Named Acting General Counsel for BD

January 7, 2023

Pfizer Expands ‘An Accord for a Healthier World’ Product Offering to Include Full Portfolio for Greater Benefit to 1.2 Billion People in 45 Lower-Income Countries

January 18, 2023

...

Medtronic recommends rejection of below-market mini-tender offer by TRC Capital Investment Corporation

January 26, 2023

...

Ford Joins the Virtual Power Plant Partnership as a Founding Member to Support Grid Resiliency and Emissions Reductions

January 11, 2023

...

Ford’s John Savona to Retire in March, Closing 33-Year Career; Bryce Currie Will Lead Americas Manufacturing, Labor Affairs

January 12, 2023

...

KKR Appoints Tim Lawler as Executive Advisor

January 18, 2023

...

Marriott International Announces Instant Booking Solution for Meetings and Events With Groups360

January 19, 2023

...

Emerson Announces Premium, All-Cash Proposal to Acquire National Instruments for $53 Per Share

January 18, 2023

...

AkzoNobel using 100% renewable electricity in North America

January 26, 2023

...

Hilton Unveils New Brand, Spark by Hilton, a Value‑Driven Offering That Proudly Delivers Reliable Essentials and Friendly Service

January 12, 2023

...

NORTH AMERICAN BUSINESS (www.na-biz.com) is a leading source of business and corporate news, information, industry trends, market updates and insights across a broad spectrum of industries in North America and worldwide.

INDUSTRIES

  • Aero
  • Agriculture
  • ALL
  • Automotive
  • Business Service
  • Chemical
  • Construction
  • Construction Materials
  • Consumer
  • Education
  • Energy
  • Entertainment
  • Environmental
  • F&B
  • Financial
  • Healthcare
  • Hospitality
  • Industrial
  • IT
  • IT Hardware
  • Logistic
  • Metal & Mining
  • Packaging & Paper
  • Rail
  • Real Estate
  • Telecom

CONTACT US

EDITORIAL:     editor#na-biz.com

PARTNERSHIP:     biz#na-biz.com

HUMAN RESOURCE:     hr#na-biz.com

* (replace # with @)

  • Official Site

Copyright © NA-BIZ.COM All rights reserved.

No Result
View All Result
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

Copyright © NA-BIZ.COM All rights reserved.