FDA Approvals, News & Updates

On September 27, 2018, the FDA approved the targeted therapy dacomitinib (Vizimpro; Pfizer), an oral kinase inhibitor, for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) associated with EGFR exon 19 deletion or exon 21 L858R substitution mutations, as identified by an FDA-approved test. Read Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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