Oncology: Tissue-Agnostic Indications Advance Under US FDA's Breakthrough Umbrella
Merck's Keytruda may not be only oncologic with indication for cancer patients defined by molecular signature, not tissue of origin, for long: Ignyta's entrectinib and Loxo Oncology's larotrectinib are positioned for breakthrough-designated tissue-agnostic NDA submissions in NTRK fusion-positive cancers in 2018.
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US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective
Tecentriq and Keytruda's apparently lower efficacy in low PD-1/L1 patients in ongoing first-line trials prompts communication instead of restriction, underscoring FDA's emerging approach to precision medicine labeling.
Loxo’s Tissue-Agnostic Approach Brings $400m Upfront From Bayer
The German pharma signs collaboration to develop and commercialize larotrectinib and a follow-on, under a structure that enables Loxo to co-promote in the US and build commercial infrastructure.
Master Protocols In Practice
Basket trials are building a path for tissue-agnostic drug development in oncology, and plans are proceeding for more master protocols in pediatric cancers, acute myeloid leukemia and pancreatic cancer.