Drugs

China Stricter than U.S. in Cancer Drug Approvals: Study

Researchers at China’s Capital Medical University say that compared to the U.S., China appears to take a more stringent regulation toward using surrogate endpoint response rate (RR) data to support cancer drug approvals. In an open-access Cancer Medicine article, the researchers discuss their analysis of all cancer drug-indication pairs based on RR in the U.S. and China to 12/2023.

The study reviewed nearly 350 RR-supported approvals of cancer drug indications, including 249 indications for 137 drugs in the U.S. and 98 indications for 68 drugs in China.

The researchers list these findings:

compared to the U.S., China appears to take a more stringent regulation toward using RR data to support drug approvals.
compared to the U.S., China’s regulation tends to require higher RR magnitude to support approval; and
the proportion of accelerated approval withdrawals in China was only 1%, while it was 10.4% in the U.S.

“Since surrogate endpoint does not mean an extension of survival and approval is influenced by regulatory authorities and policy experts,” the article concludes, “these authorities and experts in both countries may require considering a balance between quantity and quality when relying on surrogate endpoints as evidence.”

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