FDA Approvals, News & Updates
On September 28, 2018, the FDA approved cemiplimab-rwlc injection (Libtayo; Regeneron), a new immune checkpoint inhibitor, for the treatment of patients with metastatic cutaneous squamous-cell carcinoma (CSCC) or locally advanced CSCC who are not eligible for surgery or radiation. Read More ›
On October 5, 2018, the FDA approved the expanded use of the human papillomavirus (HPV) vaccine Gardasil 9 (9-valent vaccine, recombinant; Merck) to include men and women between the ages of 27 and 45 years. Read More ›
On August 8, 2018, the FDA approved mogamulizumab-kpkc (Poteligeo; Kyowa Kirin) injection, a monoclonal antibody, for use after at least 1 other systemic therapy, for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome—2 uncommon types of non-Hodgkin lymphoma that have few or no FDA-approved treatment options. Read More ›
On September 13, 2018, the FDA approved moxetumomab pasudotox-tdfk (Lumoxiti; AstraZeneca), an intravenous CD22-directed cytotoxin, for adults with relapsed or refractory hairy-cell leukemia (HCL) who received ≥2 systemic therapies, including treatment with a purine nucleoside analog. Read More ›
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 More ›
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 More ›
On August 16, 2018, the FDA approved lenvatinib (Lenvima; Eisai) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read More ›
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 More ›