Drugs

FDA Accepts Eisai sNDA for Liver Cancer Therapy

FDA has accepted for review an Eisai supplemental NDA for Lenvima (lenvatinib) for use in first-line treatment of patients with hepatocellular carcinoma (liver cancer). The submission is based on data from the pivotal Phase 3 REFLECT trial. In the study, lenvatinib reportedly demonstrated a treatment effect on overall survival by statistical confirmation of non-inferiority to sorafenib. “This is the first positive Phase 3 study of a systemic treatment in comparison to sorafenib in this patient population,” the company says. “Additionally, patients experienced statistically significant and clinically meaningful improvements in the secondary efficacy endpoints of progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR).” Lenvima is currently FDA approved for treating thyroid and kidney cancer.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome