Exelixis seeks expanded indication for cabozantinib in RCC

 

Exelixis has submitted a supplemental New Drug Application to the Food and Drug Administration for cabozantinib (Cabometyx) for the treatment of previously untreated advanced renal cell carcinoma (RCC).

The application, announced on Aug. 16, seeks to allow the manufacturer to modify the label. Cabozantinib was approved in April 2016 for treatment of patients with advanced RCC who had previously received antiangiogenic therapy.

A phase 2 trial of cabozantinib (60 mg tablets once daily) met the investigators’ primary endpoint of showing improved progression-free survival, compared with sunitinib (50 mg once daily, 4 weeks on, followed by 2 weeks off). The 157 patients in the CABOSUN trial had previously untreated advanced or metastatic RCC and an assessment of intermediate or poor risk using the International Metastatic Renal Cell Carcinoma Database Consortium risk model.

The results of the trial were published in the Journal of Clinical Oncology (2017 Feb 20;35[6]:591-7). An independent review committee confirmed the primary efficacy endpoint results in June 2017.

dwatson@frontlinemedcom.com

 

Exelixis has submitted a supplemental New Drug Application to the Food and Drug Administration for cabozantinib (Cabometyx) for the treatment of previously untreated advanced renal cell carcinoma (RCC).

The application, announced on Aug. 16, seeks to allow the manufacturer to modify the label. Cabozantinib was approved in April 2016 for treatment of patients with advanced RCC who had previously received antiangiogenic therapy.

A phase 2 trial of cabozantinib (60 mg tablets once daily) met the investigators’ primary endpoint of showing improved progression-free survival, compared with sunitinib (50 mg once daily, 4 weeks on, followed by 2 weeks off). The 157 patients in the CABOSUN trial had previously untreated advanced or metastatic RCC and an assessment of intermediate or poor risk using the International Metastatic Renal Cell Carcinoma Database Consortium risk model.

The results of the trial were published in the Journal of Clinical Oncology (2017 Feb 20;35[6]:591-7). An independent review committee confirmed the primary efficacy endpoint results in June 2017.

dwatson@frontlinemedcom.com

 

Exelixis has submitted a supplemental New Drug Application to the Food and Drug Administration for cabozantinib (Cabometyx) for the treatment of previously untreated advanced renal cell carcinoma (RCC).

The application, announced on Aug. 16, seeks to allow the manufacturer to modify the label. Cabozantinib was approved in April 2016 for treatment of patients with advanced RCC who had previously received antiangiogenic therapy.

A phase 2 trial of cabozantinib (60 mg tablets once daily) met the investigators’ primary endpoint of showing improved progression-free survival, compared with sunitinib (50 mg once daily, 4 weeks on, followed by 2 weeks off). The 157 patients in the CABOSUN trial had previously untreated advanced or metastatic RCC and an assessment of intermediate or poor risk using the International Metastatic Renal Cell Carcinoma Database Consortium risk model.

The results of the trial were published in the Journal of Clinical Oncology (2017 Feb 20;35[6]:591-7). An independent review committee confirmed the primary efficacy endpoint results in June 2017.

dwatson@frontlinemedcom.com