US FDA Extends Exelixis Cancer Drug Review

The FDA has extended its review of Exelixis experimental colorectal cancer drug combination by three months. The regulator will now make a decision by March 2027 following updated safety submissions.

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FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

The United States Food and Drug Administration extended its review of Exelixis' experimental colorectal cancer drug combination by three months to March 3, 2027. Shares of the company slipped 3.5% during pre-market trading following the announcement. The extension stems from updated safety and efficacy data submitted in response to an agency information request, which regulators classified as a major amendment.

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