FDA Approvals, News & Updates

On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. Read Article ›

On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Read Article ›



Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold. Read Article ›

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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