July 6, 2011 / 8:02 PM / in 6 years

Exelixis extends timeline for thyroid cancer data

* Aims to begin FDA application by fourth quarter

* Intends to begin prostate cancer trial by year-end

LOS ANGELES, July 6 (Reuters) - Key data from a trial of experimental drug cabozantinib as a treatment for thyroid cancer is now expected in late September or early October, not mid-year as previously expected, according to the drug’s developer, Exelixis Inc (EXEL.O).

The timeline is being extended to provide more time for the trial to reach a pre-set number of “events” -- in this case either patient deaths or disease progression, the company said on Wednesday.

Exelixis Chief Executive Michael Morrissey said he is “still very optimistic about the trial,” given results from an ongoing earlier-stage thyroid cancer study as well as the selection criteria for patients in the pivotal trial.

Exelixis said it planned to begin a U.S. Food and Drug Administration application in the fourth quarter and, assuming a positive outcome, would launch sales of cabozantinib in the second half of 2012.

Cabozantinib, also known as XL184, is an oral drug designed to block vascular endothelial growth factor, as well as MET and RET, two other drivers of tumor formation. Drugs like Roche’s ROG.VX Avastin also target vascular endothelial growth factor.

Exelixis also said it has submitted to the FDA plans for a pivotal trial of cabozantinib as a treatment for certain prostate cancer patients with the combined goal of pain reduction and bone scan response. It aims to begin the trial by the end of this year.

The company said it plans to launch next year one prostate cancer trial that would measure the drug’s impact on survival and a second trial that would gauge the amount of time patients’ lived without their cancer getting worse. (Reporting by Deena Beasley; Editing by Steve Orlofsky)

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