The European Commission has approved Merck's Keytruda as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 (combined positive score [CPS] ≥1). The drug was approved Nov. 20.
The European Commission has has granted marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd) as treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Japan's Ministry of Health, Labour and Welfare has approved Myriad Genetics' BRACAnalysis Diagnostic System to help physicians determine which women with breast cancer have Hereditary Breast and Ovarian Cancer syndrome and qualify for additional medical management.
FDA granted Exact Sciences' DNA methylation based liquid biopsy test Breakthrough Device designation for detection of hepatocellular carcinoma, based on recently presented data.
FDA has accepted Bristol-Myers Squibb's supplemental Biologics License Application and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib.
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental New Drug Application to FDA seeking approval to expand the Imbruvica (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Health Canada has approved Imbruvica (ibrutinib) in combination with obinutuzumab for treatment-naïve patients with active chronic lymphocytic leukemia.
UroGen Pharma paid $10 million to Agenus Inc. for access to zalifrelimab (AGEN1884, anti-CTLA-4 antibody) for use with sustained release technology for intravesical delivery in patients with urinary tract cancers.
Project GENIE (Genomics Evidence Neoplasia Information Exchange), an initiative by the American Association for Cancer Research, is launching a five-year, $36 million research collaboration with nine biopharmaceutical companies to obtain clinical and genomic data from an estimated 50,000 de-identified patients.
The European Commission has approved Astellas' oral once-daily therapy Xospata (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukemia with a FLT3 mutation. Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation—FLT3 internal tandem duplication and FLT3 tyrosine kinase domain mutation.
