Clinical News

FDA Approves Expanded Use of HPV Vaccine Gardasil 9

November 2018, Vol 8, No 11 - FDA Approvals, News & Updates

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. The FDA initially approved Gardasil 9 in 2006 for younger people (male and female) aged 9 years to 26 years. This HPV vaccine can prevent some types of cancers, including genital and oral cancer, as well as other diseases caused by 9 variants of HPV infection. [ Read More ]

Vizimpro a New First-Line Targeted Therapy for Metastatic NSCLC with EGFR Mutations

November 2018, Vol 8, No 11 - 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. The FDA approved dacomitinib using its priority review process and granted it an orphan drug designation. [ Read More ]

Lumoxiti a New Treatment Approved for Patients with Hairy-Cell Leukemia

November 2018, Vol 8, No 11 - FDA Approvals, News & Updates

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. The FDA used its fast track and priority review for this approval, and it granted moxetumomab pasudotox-tdfk an orphan drug designation for this indication. [ Read More ]

Poteligeo Approved for 2 Rare Types of Non-Hodgkin Lymphoma

November 2018, Vol 8, No 11 - FDA Approvals, News & Updates

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. The FDA used its priority review for this approval and assigned mogamulizumab-kpkc breakthrough therapy and orphan drug designations. This is the first drug approved by the FDA specifically for the treatment of patients with Sézary syndrome. [ Read More ]