Bayer/Loxo’s larotrectinib gets speedy review in the US

Bayer/Loxo Oncology’s larotrectinib has been granted a priority review by the US Food and Drug Administration, which will consider its use to treat metastatic solid tumours carrying a certain genetic mutation.

Loxo has filed the drug as a treatment for both paediatric and adult patients whose tumours harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

NTRK gene fusions are genetic mutations resulting in the production of tropomyosin receptor kinase (TRK) fusion proteins and lead to the development of tumor growth.

Larotrectinib is an investigational tropomyosin receptor kinase (TRK) inhibitor being jointly developed by Bayer and Loxo.

"TRK fusion cancer is not limited to any organ or site of the body and occurs in both adults and children," said Scott Fields, senior vice president and head of oncology development at Bayer's Pharmaceutical Division.

"The Priority Review designation for larotrectinib may help bring this treatment option to patients, facing a high unmet medical need, as soon as possible."

A decision by the FDA is expected by November 26. Bayer said it intends to file a marketing application in Europe sometime this year.

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