The European Commission approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
FDA accepted the supplemental Biologics License Application sBLA and the European Medicines Agency has validated the Type II Variation Application for Reblozyl (luspatercept-aamt) to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions.
FDA granted Fast Track designation for ¹⁷⁷Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer.
MD Anderson Cancer Center and Generate:Biomedicines formed a strategic collaboration to jointly discover and co-develop protein therapeutics for up to five oncology targets in advanced cancers, including small-cell and non-small-cell lung cancer.
NeraCare formed a strategic partnership with SkylineDx, which includes an exclusive co-development and licensing agreement for Immunoprint, a proteomic test used to identify early-stage melanoma patients at high risk of relapse and death.
FDA has approved polatuzumab vedotin-piiq (Polivy) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified, or high-grade B-cell lymphoma, and who have an International Prognostic Index score of 2 or greater.
FDA granted priority review to Lonsurf (trifluridine/tipiracil) as monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy.
Purdue Ventures, which manages three funds to support Purdue University-connected startups, has invested $250,000 in TRIO Pharmaceuticals Inc., a cancer immunotherapeutics startup founded by a Purdue University biophysics and structural biology alumnus.
mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda (pembrolizumab) was granted Priority Medicines scheme designation by the European Medicines Agency for the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection.
ArteraAI and the American Cancer Society formed a collaboration focused on the development of AI-driven cancer therapy personalization.
