FDA has approved Onivyde (irinotecan liposome) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
FDA has accepted the supplemental New Drug Application for Augtyro (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.
MD Anderson Cancer Center and C-Biomex Ltd. have formed a strategic research collaboration agreement to co-develop CBT-001, a radioligand targeting the CA9 cancer biomarker.
BioNTech SE, a next-generation immunotherapy company, and Autolus Therapeutics plc, a clinical-stage biopharmaceutical company, have formed collaboration with the aim of advancing both companies’ autologous CAR T programs towards commercialization, pending regulatory authorizations.
FDA accepted the supplemental Biologics Application for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. FDA assigned a Prescription Drug User Fee Act goal date of Oct. 8.
Friends of Cancer Research initiated a new research partnership, Digital and Computational Pathology Tool Harmonization, or Digital PATH, Project. The project will identify factors that may contribute to variability in biomarker assessment across computational pathology platforms, propose areas for alignment in the field, and provide insights for shaping regulatory processes.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization approval of Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The European Commission has granted marketing authorization for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. Omjjara is the first authorized medicine in the EU for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or... […]
FDA approved Balversa (erdafitinib) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.
Tempus has added a novel MRD assay, xM, to its testing solutions.