Exelixis Secures FDA Acceptance of NDA for Combined Cancer Therapy

2026-02-17 17:04:16

Abstract generation in progress

Exelixis has reached a significant milestone in its clinical development pipeline: the FDA has formally accepted its New Drug Application for a combination therapy pairing zanzalintinib with atezolizumab, designed to treat adult patients with metastatic colorectal cancer. This represents an important step forward for the pharmaceutical company’s treatment strategy targeting patients who have exhausted conventional options.

STELLAR-303 Trial Establishes Clinical Foundation for NDA

The FDA’s acceptance of this NDA hinges on compelling data from the phase 3 STELLAR-303 pivotal trial. This study evaluated the dual-agent approach in patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens, as well as anti-EGFR therapy for those with RAS wild-type tumors. The clinical evidence generated through STELLAR-303 provides the regulatory foundation supporting the company’s application for this combination indication.

Dana Aftab, Executive Vice President of Research and Development at Exelixis, emphasized the importance of this development: “We look forward to collaborating with the FDA during the review process for our first NDA for zanzalintinib,” signaling the company’s commitment to navigating the regulatory pathway with the agency.

FDA Review Timeline and Market Response

The FDA has assigned a standard review designation to the application, establishing a PDUFA target action date of December 3, 2026. This timeline provides the regulatory agency approximately nine months to complete its comprehensive evaluation of the therapy’s safety and efficacy for the indicated patient population.

Market participants responded positively to the NDA acceptance announcement. In pre-market trading on NasdaqGS, Exelixis shares climbed 0.75 percent to $41.67, reflecting investor confidence in the company’s clinical progress and the potential for this combination therapy to address an unmet medical need in metastatic colorectal cancer treatment.

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