Health Canada approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
The European Commission has approved a label extension for Astellas Pharma’s Xtandi (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer who are unsuitable for salvage-radiotherapy.
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FDA revised a draft guidance to answer questions that biologics companies may have when developing promotional communications for prescription biologics including reference products,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.
