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Keytruda NSCLC Approval Will Test PD-L1 Expression

 
• By Emily Hayes

Labeling is specific for those with PD-L1 expression as measured with a new companion diagnostic and does not reference data for PD-L1 negative patients.

FDA’s approval of Merck & Co. Inc.’s Keytruda (pembrolizumab) in non-small cell lung cancer marks a turning point in development for the family of programmed death inhibitors in that it is the first approval targeted for patients with PD-L1 expression, measured with a new companion diagnostic.

On Oct. 2, the agency granted accelerated approval for Keytruda for patients with advanced (metastatic) NSCLC whose disease has progressed...

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EMA Mapping RWD Landscape To Bridge Evidence Gap For Duchenne Drugs

 
• By Vibha Sharma

A new EU study will assess the potential of existing Duchenne muscular dystrophy patient registries and other real-world data sources to address regulatory questions for emerging therapies.

US FDA Plan To Limit Studies Eligible For Pediatric Exclusivity Criticized By Industry, NORD

 
• By Sue Sutter

The agency’s proposal to award six-month pediatric exclusivity only for studies beyond those required under the Pediatric Research Equity Act will weaken the incentive and result in less research for pediatric uses, stakeholders said.

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Germany: Newly Adopted Contractual Clauses To Reshape Clinical Trial Negotiations

 
• By Neena Brizmohun

Newly enacted standard contractual clauses for negotiating clinical trial agreements in Germany appear positive for sponsors compared to the clauses that trial sites were typically requesting in the past, eg, those relating to compensation for the transfer of inventions, according to lawyers.

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Better, Faster, Quicker: EUCOPE’s Natz Urges EU Drug Regulators To Act Now – Not Wait For New Laws

 
• By Eliza Slawther

While the EU has many pieces of promising legislation in development, regulatory agencies should also prioritize making improvements within the existing framework rather than waiting for the new laws to take effect, EUCOPE secretary Alexander Natz says.

Rese-Cel CAR T Therapy Secures EMA PRIME Designation

 
• By Neena Brizmohun

Cabaletta’s rese-cel is among the latest investigational drugs that have won a place on the European Medicines Agency priority medicines scheme. Meanwhile, 11 products were denied PRIME designations.

OMUFA Reauthorization: US FDA Would Identify Rx-OTC Switch Candidates, Work With Sponsors

 
• By Kate Rawson

The Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.