FDA Approvals, News & Updates
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
On August 30, 2017, the US Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah; Novartis), a CD19-directed chimeric antigen receptor (CAR) T-cell immunotherapy, for the treatment of patients aged ≤25 years with B-cell precursor ALL that is refractory, in second relapse, or later relapse.
2018 Third Annual Oncology Guide to New FDA Approvals | June 6, 2018
On February 22, 2017, the US Food and Drug Administration (FDA) approved lenalidomide (Revlimid; Celgene), an oral IMiD, for maintenance therapy after autologous HSCT in patients with multiple myeloma.
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.
May 2018 Vol 9, No 5 | May 22, 2018
Federal health officials this week allowed a genetic testing firm to sell kits to consumers to test whether they carry gene mutations that put them at higher risk for breast and ovarian cancer.
Best Practices in Hematologic Malignancies – December 2017 Vol 8 | December 15, 2017
Daratumumab (Darzalex), in combination with pomalidomide (Pomalyst) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 2 previous therapies, including lenalidomide (Revlimid) and a proteasome inhibitor, was approved by the FDA on June 16, 2017.
Best Practices in Hematologic Malignancies – December 2017 Vol 8 | December 15, 2017
On August 1, 2017, the FDA approved enasidenib (Idhifa), an isocitrate dehydrogenase-2 inhibitor, for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) who have the IDH2 genetic mutation.
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