THE NATIONAL COMPREHENSIVE CANCER NETWORK approved the VeriStrat predictive proteomics test for inclusion in its Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer. The test is developed by Biodesix Inc.
FDA granted accelerated approval for Keytruda (pembrolizumab) for unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
The European Medicines Agency approved Eisai's request for accelerated assessment of lenvatinib for the treatment of patients with progressive radioiodine-refractory differentiated thyroid cancer.
FDA approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage cervical cancer. The new indication is approved for use in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
FDA approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
FDA granted Breakthrough Therapy designation to investigational bispecific T cell engager antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia.
The European Commission issued marketing authorization approval for Halaven (eribulin) for locally advanced or metastatic breast cancer that has progressed after at least one chemotherapeutic regimen for advanced disease.
FDA granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia.
Mylan Inc. launched Carboplatin Injection, 50 mg/5 ml, in multi-dose vials—the generic version of Bristol-Myers Squibb's Paraplatin Injection.
FDA granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of metastatic non-small cell lung cancer.
