The European Commission approved Kymriah (tisagenlecleucel), a 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 has approved the use of Cabometyx (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy.
Myriad Genetics Inc. expanded its partnership with Intermountain Precision Genomics to add a new liquid biopsy therapy selection test to its oncology portfolio.
Aadi Bioscience Inc. has received a product-specific, permanent J-code for Fyarro (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion and recommended granting marketing authorization for Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial-transition factor gene exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
Portage Biotech Inc., NCI, and Stimunity entered a Cooperative Research and Development Agreement, under which they will collaborate with NCI’s Center for Cancer Research to advance preclinical and potential clinical development of STING agonists and anti-Receptor for Advanced Glycation End products (RAGE) agents to enhance the efficacy of cancer vaccines developed in the NCI CCR Vaccine Branch.
FDA granted clearance to version 1.1 of the next generation SmartFrame Array Neuro Navigation System and Software, sponsored by ClearPoint Neuro Inc.
On April 21, the FDA Oncologic Drugs Advisory Committee voted unanimously—with 16 “yes” votes and one abstention—to affirm that randomized data are warranted with an assessment of overall survival to support the evaluation of benefit-risk of phosphoinositide 3-kinase (PI3K) inhibitors in patients with hematologic malignancies.
FDA accepted the supplemental Biologics License Application of Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate, for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.
FDA granted fast tack status to Bria-IMT for the treatment of metastatic breast cancer.
