Drugs

pCR May Not be Valid Rectal Cancer Endpoint: Study

A study raises questions about the ability of an FDA-approved surrogate endpoint — pathologic complete response (pCR) — to reliably predict improvement in long-term survival in patients diagnosed with rectal cancer. The study, by Tulane University researcher Kavin Sugumar in association with Mayo Arizona and other medical centers, was published in JAMA Network Open.

A Tulane statement says that traditionally, the success of treatments for rectal cancers has been determined by measuring overall survival, the years between a patient’s diagnosis and death. “Since 2012,” it says, “FDA has allowed pharmaceutical companies to use tumor-free status post-therapy as a surrogate for overall survival to cut down on time and expenses needed to approve new cancer treatments.”

Through a meta-analysis of 25 clinical trials involving nearly 12,000 rectal cancer patients, Sugumar and his colleagues found no statistical relationship between pCR and overall survival.

“This is about patient outcomes,” Sugumar says, “but it’s also about how we evaluate whether a new drug works. FDA has approved pCR as a substitute for a result that would normally take years to determine, but we found that pCR should not be used as a sole endpoint to determine if a cancer treatment has been effective.”

Sugumar suggests that instead of relying solely on pCR, it might be better to use a combination of surrogate endpoints, one of which could be pCR.

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