BRIEF—Bayer submits European MAA for larotrectinib for TRK fusion cancer

Germany’s largest drugmaker Bayer has submitted a marketing authorization application (MAA) for larotrectinib to the European Medicines Agency (EMA).

Larotrectinib is being investigated to potentially treat adult and pediatric patients with locally advanced or metastatic solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

“Larotrectinib has demonstrated exciting clinical responses in patients with TRK fusion cancer across various tumor types in both children and adults,” said Ulrik Lassen, Department of Oncology, Rigshospitalet, Copenhagen, Denmark.

“The regulatory submission of larotrectinib in Europe moves us closer to being able to provide a targeted treatment option to these patients for which there is currently no approved therapy,” Dr Lassen added.

Bayer and Loxo Oncology are engaged in a collaboration for the development and commercialization of larotrectinib, under a deal signed in November 2017 worth a potential $1.55 billion to the US biotech firm.

In May 2018, larotrectinib was granted Priority Review by the US Food and Drug Administration for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).