Novartis Scores Its First Tumor-Agnostic Label For Two Nearly Decade-Old Cancer Drugs
The FDA approved Tafinlar/Mekinist for BRAF V600E-mutated solid tumors, based in part on a Phase II basket trial studying more than two dozen drugs across dozens of cancers based on genetic testing.
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The drug showed a high durability of response in ROS1-positive NSCLC patients, a factor that could give it significant differentiation compared with approved agents.
GlaxoSmithKline’s checkpoint inhibitor Jemperli has gained a second indication in the US, for the treatment of mismatch repair-deficient solid tumors, affirming the company’s drive to develop a new portfolio of cancer therapies.
Keeping Track: Keytruda Claims First TMB-Based Cancer Indication; TG Therapeutics Submits First Umbralisib NDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.