Bristol-Myers Squibb announced that the FDA has placed a clinical hold on 3 combination trials evaluating its programmed death-1 inhibitor nivolumab (Opdivo) in patients with relapsed/refractory multiple myeloma.
In a press release late Wednesday, Bristol-Myers Squibb (BMS) announced that the FDA has placed a clinical hold on 3 combination trials evaluating its programmed death-1 (PD-1) inhibitor nivolumab (Opdivo) in patients with relapsed/refractory multiple myeloma.
The hold, according to the company, is in reaction to trials evaluating another anti—PD-1 agent, pembrolizumab (Keytruda), that were placed on hold following patient deaths. In July, Merck, which has developed pembrolizumab, announced that the FDA’s decision applied to KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023; the trials were evaluating the drug in combination with various other agents in either treatment-naïve or relapsed/refractory patients with multiple myeloma.
Earlier this week, the FDA followed up with a more detailed analysis of what resulted in the deaths—higher rate of grade 3 to 5 toxicities, higher rate of serious adverse events, and some non-cancer causes of death, including cardiac events and intestinal ischemia.
Nivolumab trials that have been placed on partial clinical hold include:
Other nivolumab studies for indications other than multiple myeloma will continue as planned, according to the BMS release.
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
Low-Volume Hospitals Had Higher Reoperation Rate, Postoperative Complications in CRC
April 18th 2024Patients opting for elective colorectal surgery to address colorectal cancer (CRC) could have different rates of reoperation and postoperative complications based on the size of the hospital.
Read More