BeiGene Ltd. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer.
Exact Sciences Corp. announced the launch of Cologuard Plus, the most accurate noninvasive colorectal cancer screening test reported in studies to date. FDA-approved for average-risk patients 45+ and covered by Medicare, the Cologuard Plus test detects 95% of colorectal cancers at 94% specificity in the U.S. screening population.
FDA approved cabozantinib (Cabometyx) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.
FDA approved Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), a next-generation PSMA-PET imaging agent for prostate cancer.
FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
The European Commission has granted approval to Breyanzi, a CD19-directed CAR T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
The Center for Drug Evaluation of China’s National Medical Products Administration granted Breakthrough Therapy designation to olverembatinib, combination with low-intensity chemotherapy, for the first-line treatment of newly-diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.
FDA granted Orphan Drug designation to rhenium obisbemeda (186Re) for the treatment of leptomeningeal metastases in patients with lung cancer.
FDA approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (≥1).
