Seattle Genetics Inc. and Astellas Pharma Inc. said FDA has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors.
Hologic, Inc. said the Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology has received PMA approval from FDA and are now available on the 3Dimensions breast tomosynthesis system.
Bristol-Myers Squibb Co. said FDA has accepted its supplemental Biologics License Application for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adults with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Novartis announced the FDA has expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.
FDA approved Adcetris (brentuximab vedotin) for adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.
The University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center is now certified to offer CAR-T cell therapy.
FDA has granted Breakthrough Therapy Designation for erdafitinib in the treatment of urothelial cancer.
FDA has accepted a supplemental New Drug Application and granted priority review for Keytruda (pembrolizumab), an anti-PD-1 therapy.
Eli Lilly and Co. said FDA has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
Yisheng Biopharma Co., Ltd., said the FDA has granted orphan drug designation for its lead immuno-oncology candidate, YS-ON-001, for pancreatic cancer.
