Health Canada approves Rozlytrek for NTRK fusion-positive, locally advanced or metastatic solid tumors.- Roche

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. Rozlytrek is Roche's first tumour-agnostic treatment which works by targeting the underlying gene mutation (NTRK) which is responsible for driving oncogenesis or the growth of cancer cells in tumours. Health Canada's Notice of Compliance with Conditions policy provides conditional authorization for new drugs with promising evidence of clinical effectiveness, for patients suffering from serious, life-threatening or severely debilitating diseases or conditions for which no drug is presently marketed in Canada or for which a significant increase in efficacy or a significant decrease in risk is demonstrated in relation to an existing drug marketed in Canada. Prior to authorization, the sponsor must undertake to design, carry out and report on confirmatory trials to verify the clinical benefit of the drug. ..