The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Bristol Myers Squibb's Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
FDA revised a draft guidance to answer questions that biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars.
FDA approved Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test.
FDA approved Lumisight (pegulicianine) in adults with breast cancer to assist the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
MD Anderson Cancer Center and CureVac N.V. are entering a co-development and licensing agreement to develop novel mRNA-based cancer vaccines.
COTA, a leader in real-world data and analytics for oncology, is entering a collaboration with Sanofi to use RWD and artificial intelligence to increase the speed of oncology trials, including for multiple myeloma.
FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors
FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
The European Commission expanded the indication of Reblozyl (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low, and intermediate-risk myelodysplastic syndromes. This approval of Reblozyl covers all EU member states.
FDA approved Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial (The Cancer Letter, March 22, 2024).
Ipsen and Sutro Biopharma formed an exclusive global licensing agreement for STRO-003, an antibody-drug conjugate in the final stages of preclinical development which targets the ROR1 tumor antigen which is known to be overexpressed in many different cancer types including solid tumors and hematological malignancies.
