FDA approves Cabometyx for some patients with thyroid cancer
Exelixis announced that its cabozantinib tablet received FDA approval for patients aged 12 years and older who have previously treated radioactive iodine-refractory differentiated thyroid cancer.
“Before today, patients with radioactive iodine-refractory differentiated thyroid cancer who have progressed following prior [VEGF receptor-targeted therapy] were facing aggressive disease and no standard treatment option,” Marcia S. Brose, MD, PhD, who studied cabozantinib (Cabometyx, Exelixis) and serves as chief of the cancer center operation at Sidney Kimmel Cancer Center at Jefferson Torresdale Hospital, said in a press release.
The company stated a phase 3 trial of cabozantinib known as COSMIC-311 was critical to the drug’s approval. In that trial, cabozantinib was compared with placebo among patients with radioactive iodine-refractory differentiated thyroid cancer who progressed following at least two prior VEGFR-targeted therapies. An interim analysis indicated cabozantinib significantly reduced risk for disease progression or death compared with placebo (P <.0001) in the intent-to-treat population. A follow-up analysis with a median follow-up of 10.1 months showed the median PFS was 11 months for 170 patients treated with cabozantinib compared with 1.9 months for 88 patients treated with placebo (HR = 0.22; 95% CI, 0.15-0.31).
Exelixis noted that the most common adverse events among cabozantinib recipients were diarrhea, palmar-plantar erythrodysesthesia, fatigue, hypertension and stomatitis. These occurred in 25% of cabozantinib recipients.
The company stated that cabozantinib has been approved by the FDA to treat several diseases, including advanced renal cell carcinoma and hepatocellular carcinoma in patients previously treated with sorafenib.
“Exelixis is prepared to fully support expanded indication immediately,” the company stated.