In the News

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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