Drugs

FDA Urged to ‘Incentivize’ Oncology Trials

CBER director Vinay Prasad and researchers from U.S. and international universities say results of their study of oncology follow-on drugs suggest a need for regulators to incentivize within-class randomized clinical trials (RCTs). Writing in a JAMA Internal Medicine Research Letter, the authors say they analyzed all anticancer FDA approvals between 2009 and 2020, including biologics but excluding supportive care treatments, biosimilars, and novel routes of administration approvals. They wanted to examine the share of next-in-class FDA anticancer drug approvals with an RCT-based comparison with the first-in-class drug and characteristics of such RCTs.

“Study findings raise important questions about the value of next-in-class oncology drugs,” the report says. “These agents may offer benefits in specific scenarios, including overcoming resistance variants…. However, in cases where head-to-head RCTs were lacking, it is difficult to address the true therapeutic value of next-in-class drugs.”

If within-class RCTs were incentivized or even mandated, the authors conclude, the evidence would help determine whether next-in-class drugs provide meaningful advances in cancer care. “This is particularly important,” the article concludes, “given that me-too drugs have not led to price competition in oncology, and many are approved through single-group trials or studies using suboptimal outcomes.”

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