Drugs

Breast Cancer Endpoint Guidance

FDA has published a guidance, Pathological Complete Response in Neoadjuvant Treatment of High-Risk, Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval, to assist sponsors in designing trials to support marketing approval of drugs and biological products for treating high-risk early-stage breast cancer in the neoadjuvant (preoperative) setting. The main focus of the document is to discuss the use of pathological complete response (pCR) in high-risk early-stage breast cancer as a potential endpoint to support approval under the accelerated approval regulations.

FDA says the guidance is to:

describe acceptable definitions of pCR for regulatory purposes;
briefly summarize what is known about the relationship between pCR and prognosis;
describe trial designs and patient populations in which pCR may be accepted as reasonably likely to predict clinical benefit; and
provide guidance regarding trial designs to verify clinical benefit in support of traditional approval.

The guidance does not address trials of neoadjuvant endocrine therapy for breast cancer, nor does it address the use of pCR as an endpoint for approval of drugs to treat tumor types other than breast cancer. It primarily describes potential pathways to accelerated approval for drugs to treat high-risk early-stage breast cancer.

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