Kite, a Gilead Company, and Oxford BioTherapeutics Ltd. have entered into a research collaboration to evaluate five novel targets for a number of hematologic and solid tumor indications.
FDA is issuing a guidance on FDA's enforcement policy regarding certain quality standards requirements under the Mammography Quality Standards Act of 1992.
McKesson and Amgen signed a strategic agreement to improve cancer care in community oncology settings.
FDA has granted accelerated approval to Danyelza (naxitamab-gqgk) 40mg/10ml in combination with granulocyte-macrophage colony-stimulating factor for the treatment of pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
Gavreto (pralsetinib) received FDA approval for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer.
The European Commission has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
The European Medicines Agency has validated for review the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer harboring mesenchymal-epithelial transition factor gene exon 14 skipping alterations.
Keytruda (pembrolizumab) received accelerated approval from FDA in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
FDA has issued a Draft Guidance for comment describing the agency's proposed recommendations for including relevant information about oncology drug labels that have been approved for use in combination drug regimens.
