Oncology: Tissue-Agnostic Indications Advance Under US FDA's Breakthrough Umbrella
Executive Summary
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.
You may also be interested in...
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.