FDA approved the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors, and adding sentinel lymph node detection for breast cancer and melanoma to the approved indications.
FDA approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma.
The European Commission granted marketing approval for Imbruvica (ibrutinib) throughout the European Union, for relapsed or refractory mantle cell lymphoma, or chronic lymphocytic leukemia patients who have received at least one prior therapy, or in first line CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemotherapy.
Celgene Corporation and Sutro Biopharma will collaborate on developing multispecific antibodies and antibody drug conjugates.
Priority Health announced it plans to cover the FoundationOne and FoundationOne Heme genomic profiles for patients with cancer developed by Foundation Medicine Inc.
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.
