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In Brief This Week: Bristol Myers Squibb, Novartis, Athira Pharma, Legend Biotech

NEW YORK – The European Medicines Agency this week validated Bristol Myers Squibb's marketing authorization application for repotrectinib as a treatment for ROS1 inhibitor-naïve and -pretreated patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer and as a treatment for tyrosine kinase inhibitor-naïve and -pretreated adult and pediatric patients with NTRK-positive locally advanced or metastatic solid tumors. The validation of the application signals that the submission is complete and that the EMA will begin its review. The application was based on results from the Phase I/II TRIDENT-1 trial and CARE trial. Repotrectinib, marketed as Augtyro, was approved in the US for ROS1-positive NSCLC in November based on the TRIDENT-1 trial results. 

Novartis said this week that the US Food and Drug Administration has approved the firm's second US-based manufacturing facility for commercial production of Novartis' radioligands. The 70,000-square-foot facility, based in Indianapolis, is expected to allow Novartis to manufacture an additional 250,000 doses of radioligand therapies, including Pluvicto (lutetium vipivotide tetraxetan) and Lutathera (177Lu-dotatate) in 2024 and beyond.

Bothell, Washington-based Athira Pharma this week announced it has completed enrollment of its Phase II/III randomized, placebo-controlled clinical trial, dubbed LIFT-AD, assessing fosgonimeton as a treatment for mild to moderate Alzheimer's disease. The trial involves daily subcutaneous injections of placebo or fosgonimeton, which is designed to modulate the hepatocyte growth factor system and activate neuroprotective, neurotrophic, and anti-inflammatory pathways in the central nervous system. Investigators will evaluate clinical efficacy of the drug based on changes from baseline in cognition scores and in concentration of plasma neurofilament light chain, a biomarker associated with neurodegeneration and neuroinflammation. 

Legend Biotech this week announced it closed a license transaction with Novartis to develop, manufacture, and commercialize certain cell therapies targeting DLL3, including its autologous CAR T-cell therapy candidate LB2102. Under the terms of the agreement, Novartis agreed to pay Legend up to $100 million in an upfront payment and up to $1.01 billion in clinical, regulatory, and commercial milestone payments and tiered royalties. 

 In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.