September 18th 2021
Current approaches to precision medicine in oncology have been fruitful, but require better integration and utilization of available resources to inform sustainable and effective drug development and clinical care, according to Andre Goy, MD.
EU Panel Backs Entrectinib for NTRK+ Tumors and ROS1+ NSCLC
June 1st 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor an NTRK fusion, as well as for the treatment of adult patients with ROS1-positive, advanced non–small cell lung cancer not previously treated with ROS1 inhibitors.
FDA Approves Multiple Companion Diagnostics for Olaparib in HRR+ mCRPC
May 20th 2020The FDA has approved two companion diagnostics to identify patients with metastatic castration-resistant prostate cancer with homologous recombination repair mutations, making them eligible for treatment with olaparib.
FDA Approves PD-L1 IHC 28-8 pharmDx as Companion Diagnostic for Nivolumab Plus Ipilimumab in NSCLC
May 18th 2020The FDA has approved PD-L1 IHC 28-8 pharmDx for use as a companion diagnostic to identify patients with metastatic non–small cell lung cancer with PD-L1 tumor expression ≥1%, making them eligible for frontline treatment with nivolumab plus ipilimumab.
FDA Approves myChoice CDx as Companion Diagnostic for Olaparib in Ovarian Cancer
May 11th 2020The FDA has approved myChoice CDx for use as a companion diagnostic to identify patients with advanced ovarian cancer with positive homologous recombination deficiency status, making them eligible to receive frontline maintenance treatment with olaparib plus bevacizumab.
Oncology Clinical Trials Should Reflect Molecular Advances, Real-World Patients
May 11th 2020From the earliest moments of medical school instruction, through residency and fellowship training, physicians are taught the primacy of the randomized phase 3 trial in the hierarchy of evidence-based medicine.
FDA Approves FoundationOne CDx as Pemigatinib Companion Diagnostic in FGFR2+ Cholangiocarcinoma
April 21st 2020The FDA has approved FoundationOne CDx as the registrational companion diagnostic for pemigatinib, which the agency recently approved for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic FGFR2+ cholangiocarcinoma.