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Puma's Nerlynx Scores Broad Label Across Adjuvant Breast Cancer Subgroups

 
• By Emily Hayes

US FDA labeling details the differences in performance of neratinib in adjuvant breast cancer by subgroup, as well as results relative to the timing of Roche's Herceptin, but the drug's indication covers all.

Puma Biotechnology Inc. scored a major victory with a broad approval of Nerlynx for early-stage HER2+ breast cancer by the US FDA, even though the disease-free survival benefit in the pivotal ExteNET study was driven by particular subgroups of women.

FDA approved Nerlynx (neratinib), which is a tyrosine kinase inhibitor, on July 17 for extended adjuvant treatment of adult patients...

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Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.