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.
FDA approved Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma.
City of Hope has evaluated Curate Biosciences’ Cell Processing System for advanced cell separation and plans to integrate the platform into its workflow to manufacture investigational CAR T-cell immunotherapy, the company said.
C2i Genomics launched its C2inform minimal residual disease test across Europe after obtaining CE-IVD marking in the EU, UK, and Switzerland. The company also announced the completion of several clinical trials.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with chemotherapy and with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD-L1 (CPS ≥1).
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval 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.
