FDA approval of Cabometyx for thyroid cancer
The US Food and Drug Administration has approved Cabometyx (cabozantinib) for the additional indication of the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible, Exelixis (Nasdaq: EXEL) has announced.
The FDA granted Breakthrough Therapy designation and Priority Review to Cabometyx and its approval comes more than two months ahead of the Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021. DTC is the most common type of thyroid cancer in the USA, and patients who are resistant to radioactive iodine treatment face a poor prognosis.
Net product revenues generated by the cabozantinib franchise in the USA were $284.2 million during the second quarter of 2021, up 25% over the prior quarter.
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