The UK’s Prescription Medicines Code of Practice Authority (PMCPA) has ruled that a Roche webpage for its cancer medication Rozlytrek misled healthcare professionals.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx to be used as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group. FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for Rozlytrek (entrectinib). This decision from the FDA follows the approval of Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, FoundationOne®CDx, for the same therapy last year.
Roche said in a statement Thursday that the FDA approved a companion diagnostic from Foundation Medicine for entrectinib, which is currently being marketed as Rozlytrek. The diagnostic, called simply FoundationOne CDx, is essentially a genomic profiling tissue biopsy test that. According to Roche, it can identify the unique “fingerprint” of a solid tumor.
TOKYO, June 27, 2019 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the Ministry of Health Labour and Welfare (MHLW) granted an additional approval for FoundationOne® CDx Cancer Genomic Profile as a companion diagnostic for Rozlytrek® (entrectinib) for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion positive solid tumors on June 26, 2019. The approval enables FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic for Rozlytrek by detecting NTRK fusion genes (fusion genes between NTRK1, NTRK2, NTRK3 and other genes). Rozlytrek is a ROS1/TRK inhibitor and was approved for the treatment of adult and pediatric patients with NTRK fusion positive advanced and recurrent solid tumors on June 18, 2019.
Roche has received conditional marketing approval from the European Commission (EC) for Rozlytrek (entrectinib) to treat solid tumours in patients aged 12 years and above.
The decision is for patients over 12 years old who suffer from advanced NTRK fusion-positive solid tumours who have no satisfactory treatment options. Patients can access the treatment on the CDF when it has received marketing approval.
NICE has published final draft guidance backing NHS use of Roche's Rozlytrek (entrectinib) as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion under conditional marketing authorisation for Rozlytrek (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options. The CHMP has also recommended Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.1
MISSISSAUGA, ON, May 20, 2020 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has granted market authorization to Rozlytrek ^® (entrectinib) for the treatment of patients with ROS1 -positive, locally advanced or metastatic non-small cell lung cancer (NSCLC), not previously treated with crizotinib. ^1
Health Canada approves Rozlytrek® (entrectinib) for NTRK gene fusion-positive solid tumours in locally advanced or metastatic