Start the clock. Exelixis
Technically, we won't know how much time to put on the countdown timer until the FDA accepts the application. Exelixis requested a priority review that cuts the review time down from 10 months to six months, which I'd expect the agency to grant. In fact, investors should be a little worried if the agency gives the drug a standard review because it's a sign that the agency doesn't think cabozantinib is all that important.
Nothing is a sure thing in drug development, but an approval for cabozantinib looks fairly likely. Exelixis ran a phase 3 trial under a Special Protocol Assessment, meaning the FDA signed off on the trial design. Since the trial was positive, an approval seems likely with the usual caveats that not every piece of data, especially surrounding manufacturing, is available to investors.
Thyroid cancer will be the first indication that cabozantinib is approved for, but it isn't the one with the most potential. Cabozantinib won't have much competition in advanced medullary thyroid cancer; AstraZeneca's
Cabozantinib has a better chance of becoming a blockbuster in prostate cancer. Exelixis is running a dual strategy, looking at pain in prostate cancer patients with advanced disease, which should read out quicker, and in a separate trial it's looking at overall survival in patients who have failed Johnson & Johnson's
Prostate cancer is considerably more crowded -- there's also Dendreon's
Exelixis is a pick of David Gardner's Rule Breakers newsletter service. You can see his latest health-care find in the Fool's new free report "Discover the Next Rule-Breaking Multibagger." Get your copy for free.
Fool contributor Brian Orelli holds no position in any company mentioned. Check out his holdings and a short bio. The Motley Fool owns shares of Exelixis. Motley Fool newsletter services have recommended buying shares of Johnson & Johnson and Exelixis and creating a diagonal call position in Johnson & Johnson. The Motley Fool has a disclosure policy. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.
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