Drugs

Comments on Cross Labeling Oncology Drugs Guidance

Merck says an FDA draft guidance, Cross Labeling Oncology Drugs in Combination Regimens, is needed, given the increasing importance of oncology combination regimens for optimal patient treatment. “The guidance is informative, but does not include much information on acceptable trial design, except for a brief mention of FDA’s support for the use of historical data (pragmatic trials),” the company comment letter says. The letter reviews the ways that oncology drugs may be studied in combination and says the draft seems to focus on combination regimens that involve two unapproved drugs, with a brief mention of adding drugs to a current regimen. “Thus,” it says, “it is not entirely clear whether the guidance would apply to other types of combinations. It would be helpful if FDA were to provide clarity on whether all potential oncology combinations are subject to this guidance or only those that involve two or more investigational agents or adding a drug (unapproved or approved — for any indication) to an existing regimen.

Merck also asks FDA to clarify how to label the combination regimen for dose changes, discontinuations and interruptions, and adverse events. And it includes specific line-by-line comments.

Alkermes says it finds the guidance helpful in many respects and identifies areas that it says warrant further consideration at the agency finalizes the document.

GlaxoSmithKline and Pfizer each submitted specific line-by-line 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