NICE rejects Vitrakvi to treat neurotrophic tyrosine receptor kinase fusion-positive solid tumours.- Bayer HealthCare
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Bayer announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval of larotrectinib in China for the treatment of adult and pediatric patients with advanced solid tumors that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from Roche, intended for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Hoffmann-La Roche Limited announces that on February 10, 2020, Health Canada, under the Notice of Compliance with Conditions (NOC/c) policy, approved Rozlytrek (entrectinib) for adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.