FDA approved updated labeling for Xeloda (capecitabine) tablets under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
FDA approved Tecentriq (atezolizumab) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma.
FDA has granted an accelerated approval to Krazati (adagrasib), a RAS GTPase family inhibitor, for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
FDA has approved Rezlidhia (olutasidenib) capsules for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.
The European Commission approved Libtayo (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.Â
Genentech, a member of the Roche Group, voluntarily withdrew the U.S. indication of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
Neogene Therapeutics Inc., a global clinical-stage biotechnology company pioneering the discovery, development, and manufacturing of next-generation T cell receptor therapies, will be acquired by AstraZeneca.
FDA has granted accelerated approval to Elahere for the treatment of adult patients with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.Â
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.
Fox Chase Cancer Center and Oryzon Genomics S.A. formed a collaboration to test the safety and efficacy of the drug iadademstat in patients with pulmonary and extrapulmonary neuroendocrine carcinomas, which are rare and heterogeneous cancers arising from neuroendocrine cells, and small cell lung cancer.
