2018 Third Annual Oncology Guide to New FDA Approvals
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
On April 17, 2017, the US Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq; Genentech), a monoclonal antibody intravenous (IV) inhibitor of programmed-cell death ligand-1 (PD-L1), as detected by the FDA-approved test, as a front-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
On August 3, 2017, the FDA granted an accelerated approval for the new combination of daunorubicin and cytarabine liposome (Vyxeos; Jazz Pharmaceuticals), an intravenously infused drug, for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
On October 18, 2017, Yescarta (axicabtagene ciloleucel; Kite Pharma) was approved by the US Food and Drug Administration (FDA) for the treatment of adults with certain types of relapsed or refractory large B-cell lymphoma after receiving 2 or more lines of systemic therapy; these types include DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
Using its priority review process, on March 27, 2017, the FDA approved niraparib (Zejula; Tesaro), an oral PARP inhibitor, for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors have completely or partially responded to platinum-based chemotherapy.
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Results 11 - 15 of 15
Results 11 - 15 of 15