Cabometyx growth trends
In the first quarter, Exelixis’s (EXEL) Cabometyx witnessed more than a 20% sequential rise in prescription volume driven by both new patient starts and a robust rise in the total number of patients on the therapy.
According to a report, ~295,000 people across the world are diagnosed with kidney cancer every year, while 134,000 kidney cancer patients die every year. According to the American Cancer Society’s Cancer Facts & Figures 2018, the annual incidence of kidney cancer in the United States is ~65,000, while the annual death toll of the disease is 15,000. Another report estimates that almost 70%–75% of renal cell cancer (or RCC) patients suffer from clear cell RCC.
In this context, the American Cancer Society’s Cancer Facts & Figures 2015 has estimated the total number of RCC patients eligible for Cabometyx therapy in second-line or later settings to be ~37,000 globally. Of those eligible, 17,000 patients are in the United States.
Another report from 2014 has estimated the total number of RCC patients eligible for first-line Cabometyx therapy to be ~32,000 globally, of whom 14,000 are in the United States.
These statistics highlight the level of underserved market opportunity for Cabometyx in the RCC space.
Label expansion strategy
The capsule formulation of cabozantinib, Cometriq, is approved in a medullary thyroid cancer indication, while the tablet formulation, Cabometyx, is approved in all lines of treatment for RCC.
On March 15, Exelixis filed a supplemental new drug application (or sNDA) to the FDA seeking approval for Cabometyx in second-line plus advanced hepatocellular carcinoma (or HCC) indications.
On March 28, Ipsen announced that the European Medicines Agency (or EMA) had validated its application for expanding Cabometyx’s label in second-line plus HCC indications.
In the next article, we’ll discuss label expansion programs for Cabometyx in greater detail.