Drugs

Streamlined Cancer Trials Can Cause ‘Discomfort’: Singh

FDA Division of Oncology director Harpreet Singh says efforts to streamline oncology clinical trials can produce discomfort in investigators over issues such as safety reporting being not as rigorous as investigators expect FDA to want. Singh was a panelist on an American Society of Clinical Oncology podcast, discussing FDA’s work with the Southwest Oncology Group on the Pragmatica-Lung Trial.

The trial lead investigator, Karen Reckamp, says the Phase 3 trial of pembrolizumab (Merck’s Keytruda) and ramucirumab (Lilly’s Cyranza) is an effort to reduce clinical trial timelines and potentially move the treatment to patients more quickly than standard registrational, randomized Phase 3 trials.

The trial looks only at overall survival, Reckamp says, and strips away all unnecessary data collection that comes with other types of registrational issues in randomized Phase 3 trials.

“One very difficult lesson that I’ve had to learn,” Singh says, “is that you really have to learn to say no to some very interesting trial elements that are not essential to the big question here, which is, does this combination regimen offer an improvement in survival over the control.”

The panelists also discussed the role and use of real-world evidence and real-world data as part of an effort to make the trial results more useful in clinical practice.

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