The Centers for Medicare and Medicaid Services published two draft local coverage determinations for prostate cancer tests. The drafts were issued through Medicare contractor Palmetto GBA's MolDx Program.
FDA approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma.
FDA granted priority review to the investigational bispecific T-cell engager antibody construct blinatumomab for the treatment of adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.\
FDA granted priority review status to lenvatinib mesylate as a treatment for progressive radioactive iodine-refractory differentiated thyroid cancer.
MYRIAD GENETICS Inc. established a Tumor BRACAnalysis CDx laboratory in Munich.
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.
