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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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EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.