Drugs

Praise for Nervous System Metastases Draft Guidance

Four stakeholders are praising the FDA draft guidance on evaluating cancer drugs in patients with central nervous system (CNS) metastases and offering suggested changes. Bristol-Myers Squibb says the draft guidance is intended to provide clarity on study procedures and data requirements to support a label claim for benefit to CNS metastases. The comment letter says certain sections of the guidance may require clarification in the context of current clinical practice, and gives its recommendations for those sections.

Novartis asks that the draft include a discussion of how estimands framework in clinical development may have an impact on study designs in the context of CNS metastases.

Regeneron says it commends the agency’s initiative to provide sponsors with guidance around the appropriate design considerations for clinical trials with system anticancer drugs where patients with CNS metastases are included and where CNS anti-tumor activity is intended to be described in product labeling. It offers suggestions it believes will further strengthen the guidance and help ensure that sponsors will be best placed to adequately collect data on CNS anti-tumor activity of systemic anticancer drugs, thus benefiting patients with CNS metastases that need additional evidence-based treatment options.

Finally, Merck says there are several areas in the guidance for which it has comments and asks for clarification.

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