Bristol Myers Squibb has announced today that the FDA accepted the precedence evaluation for the Biologics License Application (BLA) for the fixed combination dose of relatlimab (Bristal Myers Squibb) and nivolumab (Bristol Myers Squibb)—lymphocyte-activation gene (LAG)-3 blockers—administered as a single infusion, for the treatment of patients 12 years or older and weighing at least 40kg diagnosed with unresectable or metastatic melanoma. The Prescription Drug User Fee Act (PDUFA) date is ready for March 19, 2022.1
“Even we’ve seen important 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, Princeton, New Jersey.
The BLA was supported by the efficacy and safety data results of the Phase 2/3 RELATIVITY-047 (NCT03470922) trial, which has demonstrated a statically important and clinically meaningful progression-free survival good thing about a mix remedy over the standard of care anti-PD-1 monotherapy in metastatic melanoma, based on the press release. Reportedly, relatlimab is the primary LAG-3-blocking antibody to demonstrate a clinical profit for patients with Phase 3 data.
The primary results from the trial had been offered at the American Society of Clinical Oncology (ASCO) annual meeting in June of 2021. The fixed-dose combination of relatlimab and nivolumab is just not approved to be used and remains to be an investigational therapy.
Chang stated, “Based mostly on the outcomes of the RELATIVITY-047 trial, we believe that the relatlimab and nivolumab fixed-dose combination has the potential to enhance outcomes for patients with metastatic or unresectable melanoma. We stay up for probably introducing the primary LAG-3-blocking antibody, and Bristol Myers Squibb’s third distinct checkpoint inhibitor, to assist patients in need.”
1. 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. Accessed September 21, 2021. https://news.bms.com/news/details/2021/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-LAG-3-Blocking-Antibody-Relatlimab-and-Nivolumab-Fixed-Dose-Combination-as-Treatment-for-Patients-with-Unresectable-or-Metastatic-Melanoma/default.aspx