Drugs

Researchers See Breakthrough Therapy Value in Cancer

An analysis funded by Friends of Cancer Research finds that the breakthrough therapy designation criteria “accurately identify drugs that improve long-term outcomes for patients with cancer and warrant coordinated efforts to ensure timely coverage decisions and access for patients.” The findings were published in Clinical Cancer Research.

The researchers compared drugs indicated to treat non-small cell lung cancer approved with or without a breakthrough therapy designation between 1/2013 and 10/2021. They found that breakthrough therapy drugs reduced the risk of death by a median of 31% and disease progression by a median of 48%, while drugs never receiving a breakthrough designation reduced the risk of death and progression by 15% and 41.9% respectively.

“A coordinated, well-supported, and timely process for determining coverage of breakthrough designation products is necessary to ensure the value brought by breakthrough designation facilitates earlier patient access to effective treatments,” the researchers conclude.

Since this analysis involved only drugs indicated for treating non-small cell lung cancer, the researchers call for a comprehensive analysis comparing outcomes data supporting approvals of breakthrough and non-breakthrough drugs for all oncology indications.

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