FDA approves cabozantinib for the frontline treatment of advanced RCC

The Food and Drug Administration has approved cabozantinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC).

The drug was approved in 2016 for patients who had received prior antiangiogenic therapy.

The expanded approval was based on improvement in progression-free survival when compared with sunitinib in the phase 2 CABOSUN trial of 157 patients with previously untreated RCC, according to a statement from the company.

Updated results of the trial, presented at the European Society for Medical Oncology 2017 Congress, demonstrated a statistically significant 52% reduction in the rate of disease progression or death (hazard ratio, 0.48; 95% confidence interval, 0.31-0.74, two-sided P = .0008). Median progression-free survival for cabozantinib was 8.6 months versus 5.3 months for sunitinib. Results of the trial were first presented at the ESMO 2016 Congress, and published in the Journal of Clinical Oncology.

Grade 3 or 4 adverse reactions were reported in 68% of patients receiving cabozantinib, compared with 65% of patients receiving sunitinib. The most frequent adverse reactions in patients treated with cabozantinib were hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, increased ALT, decreased appetite, stomatitis, pain, hypotension, and syncope. Approximately one-fifth of patients discontinued treatment in both arms.

Cabozantinib is marketed as Cabometyx by Exelixis.

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The Food and Drug Administration has approved cabozantinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC).

The drug was approved in 2016 for patients who had received prior antiangiogenic therapy.

The expanded approval was based on improvement in progression-free survival when compared with sunitinib in the phase 2 CABOSUN trial of 157 patients with previously untreated RCC, according to a statement from the company.

Updated results of the trial, presented at the European Society for Medical Oncology 2017 Congress, demonstrated a statistically significant 52% reduction in the rate of disease progression or death (hazard ratio, 0.48; 95% confidence interval, 0.31-0.74, two-sided P = .0008). Median progression-free survival for cabozantinib was 8.6 months versus 5.3 months for sunitinib. Results of the trial were first presented at the ESMO 2016 Congress, and published in the Journal of Clinical Oncology.

Grade 3 or 4 adverse reactions were reported in 68% of patients receiving cabozantinib, compared with 65% of patients receiving sunitinib. The most frequent adverse reactions in patients treated with cabozantinib were hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, increased ALT, decreased appetite, stomatitis, pain, hypotension, and syncope. Approximately one-fifth of patients discontinued treatment in both arms.

Cabozantinib is marketed as Cabometyx by Exelixis.

[email protected]

The Food and Drug Administration has approved cabozantinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC).

The drug was approved in 2016 for patients who had received prior antiangiogenic therapy.

The expanded approval was based on improvement in progression-free survival when compared with sunitinib in the phase 2 CABOSUN trial of 157 patients with previously untreated RCC, according to a statement from the company.

Updated results of the trial, presented at the European Society for Medical Oncology 2017 Congress, demonstrated a statistically significant 52% reduction in the rate of disease progression or death (hazard ratio, 0.48; 95% confidence interval, 0.31-0.74, two-sided P = .0008). Median progression-free survival for cabozantinib was 8.6 months versus 5.3 months for sunitinib. Results of the trial were first presented at the ESMO 2016 Congress, and published in the Journal of Clinical Oncology.

Grade 3 or 4 adverse reactions were reported in 68% of patients receiving cabozantinib, compared with 65% of patients receiving sunitinib. The most frequent adverse reactions in patients treated with cabozantinib were hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, increased ALT, decreased appetite, stomatitis, pain, hypotension, and syncope. Approximately one-fifth of patients discontinued treatment in both arms.

Cabozantinib is marketed as Cabometyx by Exelixis.

[email protected]