Oncology center of excellence guidance documents. Project Orbis: Global Collaborative Review Program. FDA News Release: FDA approves first new drug under international collaboration, a treatment option for patients with HER2-positive metastatic breast cancer. Over the course of 2020, Project Orbis led to 17 new molecular entity or new active substance approvals and 32 supplemental drug approvals for new indications. In May 2020, the FDA also welcomed the Brazilian Health Regulatory Agency (ANVISA) to join this international partnership. The FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority (Singapore) and Swissmedic (Switzerland) collaborated on the application review for tucatinib. The FDA is the primary coordinator for drug application selection and review in this programme, although each country remains completely independent with regard to their final regulatory decision and drug labelling. This project provides a framework for concurrent submission and review of oncology drugs among international partners, with the goal of providing patients faster access to drugs in countries in which substantial delays in drug application submission and review might occur 2. In 2020, tucatinib, in combination with trastuzumab and capecitabine for patients with metastatic HER2-positive breast cancer (including those with brain metastases), was the first new molecular entity reviewed under the Oncology Center of Excellence (OCE) Project Orbis 1. Finally, pembrolizumab was the first immune-checkpoint inhibitor approved for first-line treatment of patients with metastatic microsatellite instability-high or mismatch repair-deficient colorectal cancer, and brexucabtagene autoleucel became the first chimeric antigen receptor T cell therapy approved for mantle cell lymphoma. Selpercatinib was the first agent approved to treat NSCLC, medullary thyroid cancer and other thyroid cancers harbouring RET alterations. Other approval ‘firsts’ this year included relugolix, the first oral androgen-deprivation therapy for advanced-stage prostate cancer sacituzumab govitecan-hziy, the first antibody–drug conjugate (ADC) targeting Trop-2 for metastatic triple-negative breast cancer mitomycin gel for low-grade upper tract urothelial cancer selumetinib for paediatric patients with neurofibromatosis type 1 with inoperable symptomatic plexiform neurofibromas avapritinib for metastatic gastrointestinal stromal tumours harbouring PDGFRA exon 18 mutations and tazemetostat for metastatic epithelioid sarcoma.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |