FDA grants priority review for Bayer, Loxo Oncology's larotrectinib in TRK fusion cancers

Bayer announced Tuesday that the FDA granted priority review to a marketing application submitted by partner Loxo Oncology for larotrectinib to treat adult and paediatric patients with locally advanced or metastatic solid tumours harbouring a neurotrophic tyrosine receptor kinase (TRK) gene fusion. The US regulator is expected to render its decision by November 26. 

Bayer entered into a partnership with Loxo last year in a deal worth potentially more than $1.5 billion to jointly develop larotrectinib, as well as LOXO-195, for the treatment of cancers associated with TRK gene fusions. Interim study data unveiled in June 2017 showed that larotrectinib was associated with an objective response rate of 76 percent across tumour types in patients harbouring TRK fusions. 

Scott Fields, head of oncology development at Bayer's pharmaceutical division, remarked "the priority review designation for larotrectinib may help bring this treatment option to patients, facing a high unmet medical need, as soon as possible." The treatment, formerly known as LOXO-101, has also received breakthrough therapy, orphan drug and rare paediatric disease designations from the FDA. 

Meanwhile, Bayer indicated that it also expects to submit larotrectinib for authorisation in Europe this year. Analysts have forecast annual sales of $500 million to $1 billion for the treatment. 

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