FDA Approvals, News & Updates

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 ]

Kisqali Receives Expanded Indications for HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

October 2018, Vol 8, No 10 - FDA Approvals, News & Updates

On 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 ]

Opdivo plus Yervoy Approved for MSI-H or dMMR Colorectal Cancer

October 2018, Vol 8, No 10 - FDA Approvals, News & Updates

On July 10, 2018, the FDA accelerated the approval of the combination of nivolumab and ipilimumab (Opdivo and Yervoy; Bristol-Myers Squibb) for the treatment of patients aged ≥12 years with metastatic c­o­lorectal cancer (CRC) associated with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) that progressed after chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan. [ Read More ]