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FDA Breast Cancer Guidance Paves Way For Accelerated Approval With One Trial

 
• By Emily Hayes

FDA draft guidance lays out use of pathologic complete response to support accelerated approval of drugs for women with high-risk, early-stage breast cancer. Pathway allows for initial approval based on one pivotal study, which could be extended to assess survival and confirm clearance.

FDA’s draft guidance on use of pathological complete response to support accelerated approval of drugs for neoadjuvant treatment of breast cancer lays the groundwork for using only one clinical trial, with response rate as a surrogate endpoint and an extension to look at survival to fulfill the requirement for confirmatory evidence.

The draft guidance issued May 29 addresses accelerated approval of drugs for early-stage, high-risk breast cancer in the neoadjuvant setting (before surgery) as add-on treatment to regimens typically given post-operatively, with the goal of enabling sponsors to use pathologic complete response rate (pCR)

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• By Francesca Bruce

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More from R&D

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.