Loxo, Bayer get quick FDA review for ‘precision’ cancer drug
Loxo Oncology and Bayer should hear from the FDA about their tumour biomarker-targeted cancer drug larotrectinib by 26 November, after picking up a priority review by the US regulator.
TRK inhibitor Larotrectinib is being reviewed by the US regulator for adult and paediatric patients with locally advanced or metastatic solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion biomarker, a departure from the usual regulatory route of seeking approval based on the organ or tissue where the cancer starts to grow.
In trials presented at last year’s American Society of Clinical Oncology (ASCO) meeting and since published in the New England Journal of Medicine (NEJM), larotrectinib achieved a 75% overall response rate (ORR) in TRK fusion cancers, including 13% complete responses and 62% partial responses.
Read more: http://www.pmlive.com/pharma_news/loxo,_bayer_get_quick_fda_review_for_precision_cancer_drug_1237511
TRK inhibitor Larotrectinib is being reviewed by the US regulator for adult and paediatric patients with locally advanced or metastatic solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion biomarker, a departure from the usual regulatory route of seeking approval based on the organ or tissue where the cancer starts to grow.
In trials presented at last year’s American Society of Clinical Oncology (ASCO) meeting and since published in the New England Journal of Medicine (NEJM), larotrectinib achieved a 75% overall response rate (ORR) in TRK fusion cancers, including 13% complete responses and 62% partial responses.
Read more: http://www.pmlive.com/pharma_news/loxo,_bayer_get_quick_fda_review_for_precision_cancer_drug_1237511