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FDA Eyeing Other PD-1/L1 Drugs With Clinical Hold On Keytruda Myeloma Trials

 
• By Michael Cipriano

Merck previously disclosed the clinical hold on the three trials at the beginning of July; FDA says its announcement is meant to inform patients and healthcare providers about the danger of the safety signal.

Yellow road sign with a blue sky and white clouds: clinical trial
US FDA has detailed the data that led to a clinical hold on Keytruda multiple myeloma trials

The US FDA announced it is expanding its investigation into the broader field of PD-1/PD-L1 cancer drugs more than a month after the news of a clinical hold on three of Merck & Co. Inc.'s multiple myeloma clinical trials for Keytruda (pembrolizumab).

Merck announced the hold July 5, pausing three combination trials of Keytruda with Celgene Corp.'s immunomodulatory thalidomide analogues Pomalyst...

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

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Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
• By Neena Brizmohun

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.