FDA Approvals, News & Updates

On April 28, 2017, midostaurin (Rydapt; Novartis), a kinase inhibitor, became the first targeted therapy, and the first new drug in more than 20 years, to receive FDA approval, in combination with chemotherapy, for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) plus the FLT3 mutation.
On April 27, 2017, the kinase inhibitor regorafenib (Stivarga; Bayer HealthCare) received a new indication from the FDA for the treatment of patients with hepatocellular carcinoma (HCC) who had previously received sorafenib.
On April 17, 2017, atezo­lizumab (Tecentriq; Genentech), a PD-L1–blocking antibody, received a new indication by the FDA as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
On March 23, 2017, the FDA accelerated the approval of avelumab (Bavencio; EMD Serono/Pfizer), PD-L1–blocking antibody, for the treatment of adults and pediatric patients aged ≥12 years with metastatic Merkel-cell carcinoma.
“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” said Richard Pazdur, MD, Acting Director of the FDA’s Center for Drug Evaluation and Research and Director of the FDA’s Oncology Center of Excellence. “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation,”
The FDA approved ribociclib, in combination with an aromatase inhibitor, for the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.
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