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.
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.
MD Anderson Cancer Center and Exscientia plc formed a strategic collaboration to align the drug discovery and development expertise of MD Anderson with the patient-centric artificial intelligence capabilities of Exscientia in order to advance novel small-molecule oncology therapies.
Organon launched the distribution of Ontruzant, a biosimilar of Herceptin, in Canada, providing an additional treatment option for Canadian adults diagnosed with early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
FDA has approved Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.
FDA has approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing EGFR mutation or anaplastic lymphoma kinase genomic tumor aberrations.
FDA approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma. This is the first pediatric approval for Adcetris.