Drugs

16% Oncology Phase 2 Patients Get Drugs Later OKd

One in six oncology patients in Phase 2 clinical trials receive treatments that are eventually approved by FDA, two Canadian researchers write in the Journal of the National Cancer Institute, adding that this represents a higher therapeutic value than Phase 1 trials.

The researchers say the proportion improved to one in five when considering National Comprehensive Cancer Network off-label recommendations, and decreased to one in 11 when considering FDA approvals deemed to present substantial clinical benefit by a European Society for Clinical Oncology scale.

The analysis hints at the possibility that certain types of trials present better prospects of receiving a therapy that advances in approval, the report says. Thus, Phase 2 trials involving biomarker enrichment or immunotherapy increased the probability of receiving a later-approved therapy to one in four. Trials testing unapproved drugs showed a therapeutic proportion of one in five, the researchers say, compared to one in 11 for trials testing approved drugs for a new indication.

“Our findings reinforce ambiguity in the classification of drug administration in Phase 2 trials,” the authors conclude. “Most patients who enroll in Phase 2 trials have advanced cancers that lack validated treatment options, as observed in this study. Many such patients are likely to regard a 16% probability of receiving a drug that later secures FDA approval for their condition as favorable odds. We think it can be appropriate to present Phase 2 trial participation as offering a small prospect of benefit.”

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