Drugs

Register Terminal Cancer Patients in Cancer Trials, FDA Says

FDA has published a draft guidance, Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings, with recommendations for including patients who have not received available therapy for their cancer in clinical trials of investigational drugs and biological products in a non-curative setting. The document says eligibility criteria for such clinical trials should generally require that patients have received available therapies that offer the potential for cure in a substantial proportion of patients in clinical trials evaluating investigational cancer drugs.

Alternatively, FDA says, such available therapy should be administered to all patients in the trial, where the investigational drug is added to such therapy. “However, eligibility criteria in which patients receive an investigational drug(s) in lieu of available therapy are reasonable in the non-curative setting when patients have been provided with adequate information to make an informed decision on trial participation,” the guidance adds.

The draft also describes the information that should be included in the informed consent when the approach is taken and includes recommendations on efficacy analyses under this approach.

Commenting on the draft, FDA Oncology Center of Excellence director Richard Pazdur says the agency believes patients with incurable cancers, if provided adequate information to make an informed decision, should be eligible to participate in oncology clinical trials. “If there is no scientific rationale for excluding these patients,” he says, “then clinical trial eligibility criteria should be broadened to include these patients, with appropriate informed consent.”

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