This week the U.S. Food and Drug Administration (FDA) approved several drugs. Here is a recap of recent drug approvals in the past few weeks.
The FDA approved Revlimid® (lenalidomide) in combination with rituximab for previously-treated follicular lymphoma (FL) and marginal zone lymphoma (MZL). In the AUGMENT trial, the median progression-free survival (PFS) was 39.4 months among patients receiving lenalidomide plus rituximab versus 14.1 months in patients receiving placebo. In the MAGNIFY trial, the objective response rate was 59% for patients with FL and 51% for patients with MZL who received lenalidomide and rituximab.
The FDA approved Piqray® (alpelisib) tablets for use in combination with the endocrine therapy fulvestrant to treat postmenopausal women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following disease progression on or after an endocrine-based regimen. This is the first PI3K inhibitor approved for the treatment of breast cancer.
The FDA approved NovoTTF-100L System in conjunction with pemetrexed plus platinum-based chemotherapy to treat unresectable malignant pleural mesothelioma (MPM). It is the first MPM treatment in 15 years to receive the FDA’s approval. The NovoTTF-100L System is a tumor treating fields device indicated for treating tumors that cannot be removed by surgery.
The FDA approved Fragmin® (dalteparin) injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged one month and older. It is the first FDA-approved therapy to treat VTE in pediatric patients.
The FDA approved ramucirumab (Cyramza®) monotherapy for the treatment of hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein of ≥400 ng/mL and have been previously treated with sorafenib. This is the first genome-driven treatment for HCC. In the REACH-2 study, ramucirumab improved overall survival, PFS, and overall response rate compared with placebo.