Exelixis' Lead-In Trial Design Evaluates Cabozantinib Disease Activity Against Multiple Cancers At 12 Weeks
This article was originally published in The Pink Sheet Daily
Novel adaptive randomized discontinuation design tested cabozantinib in nine tumor types, isolated best opportunities faster than traditional randomization.
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As cabozantinib wins FDA approval for the rare medullary thyroid cancer, Exelixis stresses its broader development program in other tumor types, notably prostate cancer. The company is likely to submit prostate cancer data to compendia, which if successful could enable reimbursement for the off-label use.
Approval in very rare medullary thyroid cancer marks an important milestone for Exelixis’ Cometriq (cabozantinib), which is being positioned for multiple cancers. The company will need only five sales reps for the thyroid cancer market and plans to launch in late January 2013 at the price of $9,900 per 28 days.
FDA has approved one drug supported by an adaptive design, but the trial did not save money or time, FDA statistician tells regulatory professionals.