Drugs

Suggestions to Change Cancer Placebo Guidance

AstraZeneca says that an FDA draft guidance on considerations for use of placebos and blinding in randomized controlled clinical trials for hematologic malignancy and oncologic disease does not address considerations for sponsor-level blinding of placebo-controlled clinical trials. “It would be helpful if the agency could provide information to be considered for maintenance of the sponsor blind and/or unblinding of the sponsor,” the company’s comment letter says. It also says that progression-free survival is a common primary endpoint in oncology trials and the guidance does not address concerns with bias in “somewhat subjective” endpoints. AZ asks the agency to provide guidance on whether blinded central adjudication is required for endpoints other than overall survival.

Bristol-Myers Squibb says the draft “is a positive step in recommending the use of placebos in blinded randomized controlled studies for the treatment of hematologic malignancies and oncologic diseases.” However, it says, the guidance scope could be refined to include considerations for blinding in placebo control studies only. “In certain sections of the proposed guidance,” BMS says, “it is vague whether the recommendations apply to any blinded randomized controlled study or just the ones that use placebos.”

Merck notes that use of a placebo control may raise problems of ethics, acceptability, and feasibility in subsequent trials or other scenarios, and may not be acceptable once some benefit has been shown. It asks FDA to give additional guidance on what a suitable comparator would be in situations where there is no standard of care and a placebo control would be inappropriate. It also asks for clarification on when and which type of external controls might be adequate to substantiate the relevance of single-arm trial data.

In its letter Roche/Genentech says the draft could be further refined to fully reflect FDA’s increased recognition of the value of patient input on patients’ experiences with disease and treatment.

Finally, Novartis submitted line-by-line specific comments.

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