FDA Approvals, News & Updates


In July 18, 2018, the FDA approved 2 new indications for ribociclib (Kisqali; Novartis) for use as (1) initial endocrine-based therapy, in combination with an aromatase inhibitor (AI), for the treatment of pre- and perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer; as well as (2) an initial endocrine-based therapy or after disease progression while receiving endocrine-based therapy, in combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. Read Article ›


On June 19, 2018, the FDA revised the prescribing label for atezolizumab (Tecentriq; Genentech) and for pembrolizumab (Keytruda; Merck) to limit the use of these 2 immunotherapies in patients with locally advanced or metastatic urothelial cancer only to patients who are ineligible for cisplatin-containing chemotherapy. Read Article ›

On August 16, 2018, the FDA approved lenvatinib (Lenvima; Eisai) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read Article ›

On August 16, 2018, the FDA accelerated the approval of nivolu­mab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with metastatic small-cell lung cancer that progressed after platinum-based chemotherapy and ≥1 other lines of therapy. Read Article ›



On July 13, 2018, the FDA approved a new indication for enzalutamide (Xtandi; Astellas) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). Enzalutamide was initially approved for metastatic CRPC in 2012. Read Article ›


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