FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved an expanded indication for the Concentric Medical Trevo clot retrieval device to allow treatment of certain stroke patients up to 24 hours after symptom onset, expanding the use to a broader group of patients. An agency news release says the device is cleared for use as an initial therapy for acute ischemic stroke to reduce paralysis, speech difficulties, and other stroke disabilities, and only as an addition to treatment with a tissue plasminogen activator that dissolves clots. The device was previously cleared for use in patients six hours after symptom onset. Risks associated with Trevo use include failure to retrieve the blood clot, embolization to new territories in the brain, arterial dissections and vascular perforations, and access site complications at the femoral artery entry point.

FDA has cleared a Mesa Biotech 510(k) for its Accula Flu A/Flu B test for use on the company’s polymerase chain reaction testing platform, which is designed for point-of-care infectious disease diagnosis. The test provides a qualitative result in about 30 minutes. It is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs.

DRUGS

FDA has approved AstraZeneca’s Imfinzi (durvalumab) for treating patients with Stage III non-small cell lung cancer whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation. This is the first treatment approved for this disease stage to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation, the agency says in a release.

FDA has approved a Janssen Pharmaceutical NDA for Erleada (apalutamide) for treating patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy (castration-resistant). An agency release says that this is the first approved treatment for non-metastatic, castration-resistant prostate cancer. The drug works by blocking the effect of androgens on a tumor.

FDA has approved a Vertex Pharmaceuticals NDA for Symdeko (tezacaftor/ivacaftor) for treating the underlying cause of cystic fibrosis in patients aged 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor. Approval was based on data from two Phase 3 studies called EVOLVE and EXPAND that enrolled about 750 people with cystic fibrosis. Across both studies, patients treated with Symdeko experienced statistically significant and clinically meaningful improvements in lung function and other measures of disease, with a favorable safety profile, the company says.

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