Drugs

Support for Minimal Residual Disease Guidance

The Leukemia & Lymphoma Society says it supports an FDA draft guidance on regulatory considerations for use of minimal residual disease (MRD) in development of drug and biologic products to treat hematologic malignancies. “We agree with FDA’s assertion that MRD as a general measure of tumor burden has multiple potential regulatory and clinical uses as a biomarker in clinical trials of drugs or biologics to treat hematologic malignancies,” the society says in a comment letter. “We consider increased use of MRD as a biomarker an important tool in expediting the development and delivery of innovative and efficacious therapies to patients with blood cancers.”

The society says it support the guidance’s clear presentation of the process sponsors may use to obtain the agency’s review and consideration of MRD as a biomarker in blood cancer clinical trials, whether in their usual interactions with review divisions during product development or through the formal drug development tool qualification process.

In its response, Merck says it supports the guidance and finds it to be clearly written and helpful to sponsors. The company says the document aligns well with the European Medicines Agency’s MRD document.

Pfizer’s comment letter says it would be helpful if the agency could address circumstances when MRD may be included in the label if it is not being assessed as the primary endpoint. It also asks for guidance on the number of MRD assessments expected (pre- and post-dose) and if confirmation of MRD-negativity is required within a certain time period.

Specific line-by-line comments were submitted by Gilead and AstraZeneca.

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