FDA approved Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
FDA granted first marketing clearance for RefleXion Medical’s SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers.
FLAG-003, an investigational small molecule therapy developed by FLAG Therapeutics Inc. for the treatment of diffuse intrinsic pontine glioma—a rare, highly aggressive and difficult to treat brain tumor found in children—has been granted Rare Pediatric Disease designation from FDA.
FDA approved Keytruda (pembrolizumab) for adjuvant treatment following resection and platinum-based chemotherapy for stage 1B, 2, or 3A non-small cell lung cancer.
FDA approved Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Thermo Fisher Scientific and AstraZeneca formed a global, multiyear agreement to develop a solid tissue and blood-based companion diagnostic test for Tagrisso (osimertinib).
Ibex Medical Analytics entered into an agreement with AstraZeneca and Daiichi Sankyo for the development, clinical validation, and early adoption of an AI-powered product to aid pathologists with an accurate and reproducible assessment of HER2 immunohistochemistry scoring in breast cancer patients.
Evotec entered into a strategic collaboration and license agreement with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration focuses on the development of first-in-class targeted immune-based therapies for oncology, which will ultimately be commercialized by Janssen. The agreement was facilitated by Johnson & Johnson Innovation.
FDA granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
FDA issued a draft guidance for industry, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.”