Sept 11 (Reuters) – The U.S. Food and Drug Administration has extended the review of Exelixis’ experimental colorectal cancer drug combination by three months, the company said in a filing on Friday.
The regulator will now make its decision by March 3, 2027.
In response to an FDA information request, Exelixis submitted updated safety and efficacy data, which the health regulator classified as a major amendment, the filing showed.
The company is seeking approval for for zanzalintinib, in combination with Roche’s immunotherapy Tecentriq for the treatment of subset of adult patients with metastatic colorectal cancer.
(Reporting by Sriparna Roy in Bengaluru; Editing by Vijay Kishore)
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