RP1, Nivolumab

BLA Accepted for Melanoma Combination Therapy, RP1 and Nivolumab
The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22, 2025.
Replimune's BLA For RP1-Nivolumab Combo Gets FDA Approval For Advanced Melanoma, Stock Surges
(RTTNews) - Replimune Group, Inc. (REPL), Tuesday announced that the U.S. Food and Drug Administration has accepted the Biologics License Application for RP1 in combination with Nivolumab for the treatment of advanced melanoma. Following the announcement, Replimune's stock is currently climbing 26.09 percent, to $12.78 on the Nasdaq.
The FDA Accepts a BLA for RP1 Plus Opdivo in Advanced Melanoma
The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have progressed on prior therapy.
REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA
Replimune Group, Inc. REPL announced that the FDA has accepted the biologics license application (BLA) for its lead pipeline candidate, RP1 (vusolimogene oderparepvec), in combination with Bristol Myers’ BMY Opdivo (nivolumab) to treat adult patients with advanced melanoma.
FDA accepts Replimune's advanced melanoma therapy BLA
Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has been accepted by the U.
Replimune announces BLA acceptance, priority review for RP1
Group announced that the U.S. Food and Drug Administration, FDA, has accepted the Biologics License Application, BLA, for RP1
Targeted Oncology14h
5-Year Update Sustains Nivolumab/Chemo Efficacy in Frontline Gastric/GEJ/Esophageal Cancer
CheckMate 649 trial showed sustained efficacy with frontline nivolumab plus chemotherapy vs chemotherapy alone in patients with gastric cancers.
Australian research makes breakthrough in boosting breast cancer cure rate
Australian researchers have made a breakthrough in improving the cure rate for the most common form of breast cancer. An ...
Healio13d
Adjuvant nivolumab improves DFS in high-risk head and neck cancer
The addition of adjuvant nivolumab to standard-of-care radiotherapy and cisplatin improved survival for patients with locally ...
Targeted Oncology14h
Nivolumab Plus Chemo Improves OS in Chinese Patients With Advanced Gastric/GEJ Cancer
The phase 3 CheckMate 649 trial showed that nivolumab plus chemotherapy significantly improved long-term overall survival in Chinese patients with advanced gastric, gastroesophageal junction, and ...
Medscape1d
How New Research Is Redefining Melanoma Treatment
Research has introduced daromun, therapeutic vaccines, and novel combinations for metastatic melanoma, reshaping the ...
Oncology Nurse Advisor10d
Nivolumab Plus Ipilimumab Bests Chemo in MSI-H, dMMR Colorectal Cancer
In the primary efficacy population, the median progression-free survival was not reached in the nivolumab-ipilimumab arm and was 5.9 months in the chemotherapy arm. The combination of nivolumab ...