Drugs

First Project Orbis Action with Australia, Canada

FDA says it has taken its first regulatory actions under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among its international partners. Under the project, FDA, the Australian Therapeutic Goods Administration and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

An agency statement says that with a framework for concurrent submission and review of oncology drugs, Project Orbis “facilitates a collaborative review to identify any regulatory divergence across review teams.”

As part of Project Orbis, FDA says it granted accelerated approval for Eisai and Merck’s Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for treating patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, and who have disease progression following prior system therapy but are not candidates for curative surgery or radiation. Lenvima was initially approved by FDA in 2015 and Keytruda was initially approved in 2014. Approval of the indication for Lenvima in combination with Keytruda was based on results of a clinical trial involving 94 patients.

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