On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
FDA Approves Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer
FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form of breast cancer.
A dizzying array of new chimeric antigen receptor (CAR) T-cell therapies targeting the B-cell maturation antigen (BCMA) designed specifically for the treatment of multiple myeloma was presented at the 2018 American Society of Hematology (ASH) annual meeting. BCMA-targeted CAR T-cell therapies are designed to improve T-cell persistence, depth of response, and tolerability. Response rates reported at ASH 2018 range from 70% to 100%, depending on the patient population and the use of previous regimens.
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. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first FDA approval in the adjuvant setting.
Brigatinib, Next-Generation ALK Inhibitor, Improves Survival versus Crizotinib in Patients with NSCLC and ALK Mutation
Brigatinib (Alunbrig), a new-generation ALK inhibitor, significantly prolonged survival compared with standard of care with crizotinib (Xalkori) as first-line therapy in patients with advanced ALK-positive non–small-cell lung cancer (NSCLC). The median progression-free survival (PFS) was not reached in the brigatinib arm versus 9.8 months in the crizotinib arm. At 1 year, 67% of the patients who received brigatinib were still alive compared with 43% of patients who received crizotinib.
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). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion.
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Results 11 - 20 of 122
Results 11 - 20 of 122