FDA Policy/General

Product Approval Summaries

DRUGS

FDA has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for treating patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. The expanded approval is intended for patients experiencing disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. Keytruda has been approved for 10 other indications, including melanoma, lung cancer, head and neck cancer and Hodgkin lymphoma.

FDA has approved a GlaxoSmithKline and Innoviva NDA for a once-daily, single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), indicated for long-term maintenance treatment of patients with chronic obstructive pulmonary disease, including chronic bronchitis or emphysema. The therapy is intended for patients who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations when additional treatment of airflow obstruction is desired or for those who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol, according to the company. Trelegy Ellipta is not indicated for relieving acute bronchospasm or treating asthma.

DEVICES

FDA has approved magnetic resonance (MR)-conditional labeling for Abbott’s Ellipse implantable cardioverter defibrillator and associated Tendril MRI pacing lead and Durata and Optisure high voltage leads. Ellipse labeling allows patients to undergo an MRI scan if needed, and patients previously implanted with an Ellipse device and Durata or Optisure leads can now undergo MRI scans, the company says. Earlier this year, Abbott’s Assurity MRI pacemaker gained MR-conditional labeling approvals in Europe.

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