FDA expedites Keytruda approval

The Food and Drug Administration (FDA) of the United States has approved Keytruda (pembrolizumab) for subsets of patients with non-small cell lung cancer. This follows approval for the provision of the drug on the NHS in England in June.

This approval came as part of the Real-Time Oncology Review Pilot Programme, which has been launched by the FDA in order to reduce delays between submission and approval, and the approach has been lauded by FDA Commissioner FDA Comissioner Scott Gottlieb, M.D.

Under the scheme, a company makes its trial data available soon after data collection finishes, allowing the FDA to begin reviewing raw data for promising medicines, well before the company makes a formal submission. This allows the FDA a head-start on assessment, in particular allowing it to resolve formatting and methodological differences between the company and the FDA prior to the clock starting.

This is only the second drug to be approved under this programme, after the approval of Kisqali (ribociclib) in July.

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Published 23. August 2018 in News