European Commission grants Bayer's cancer precision treatment drug larotrectinib to market

recently, Bayer(http:// announcedthat the European Commission has granted the European Union a market license for theof thehttp:// drug for cancer,"larotrectiniblarotrectinib is suitable for treating patients with adult and child solid tumors who are late-stage, far-stage metastases, cannot be surgically removed or have poor surgical efficacy, and have no satisfactory alternative treatmentlarotrectinib, as an oral TRK inhibitor, is an EU-approved anti-cancer drug that treats tumors with NTRK gene fusionlarotrectinib has shown an efficient and long-lasting response in adult and child cancer patients with TRK fusion, including central nervous system (CNS) tumors, and has been approved in the United States, Brazil and CanadaThe approval of the EuropeanMedicines(http://Authority (EMA) for larotrectinib is based on a summary of 102 patient clinicaltrial(http://dataanalyzed (http:// (93 patients from primary analytical populations, 9 patients with primary CNS tumor patients), data sources including Phase I clinical trials in adult patients, Phase II trials in adult and adolescent patients, and phase II SCOUT trials in pediatrics results in the main analysis of the population (n-93) showed that the objective mitigation rate (ORR) was 72% (95% CI: 62, 81), including 16% of full remission (CR) and 55% partial remission (PR) in another analysis of patients with primary CNS tumors, ORR was 67% (95% CI: 57, 76), including 15% OF CR and 51% PR In the summary of the main analysis (n-102), the median continuous mitigation time (mDOR) and the median progression lifetime (mPFS) were not reached at the data analysis cut-off The remission time ranged from 1.6 to 38.7 months, with 75% of patients with a duration of 12 months or more One year after the start of treatment, 88% of the patients in the main analytical population (n-93) survived (95% CI:81,95) Larotrectinib showed good safety, with most adverse events (AEs) at level 1 or 2, and only 3% of patients stopped treatment due to treatment-related AEs