Facts of COMETRIQ (cabozantinib) capsules 140mg ?

  • Medicine Name: COMETRIQ
  • Generic Name: Cabozantinib
  • Approval Date: November 29, 2012
  • Company Name: Exelixis, Inc.
  • Available as (Form & Strength): Capsules: 50 mg

Product Description

What are the indications and usage?

COMETRIQ is indicated for the treatment of pa tients with progressive, metastatic medullary thyroid cancer (MTC).

How supplied/storage and handling ?

A statistically significant prolongation in PFS was demonstrated among COMETRIQ-treated patients compared to those receiving place bo [HR 0.28 (95% CI: 0.19, 0.40); p <0.0001], with median PFS times of 11.2 months and 4.0 months in the COMETRIQ and placebo arms, respectively. Partial responses were observed only among patients in the COMETRIQ arm (27% vs. 0; p<0.0001). The median duration of objective responses was 14.7 months (95% CI: 11.1, 19.3) for patients treated with COMETRIQ. There was no statistically significant difference in overall survival between the treatment arms at the planned interim analysis. Figure 1: Progression-Free Survival 16 HOW SUPPLIED/STORAGE AND HANDLING COMETRIQ 20 mg capsules are supplied as hard gelatin capsules with grey cap and grey body, printed with “XL184 20mg” in black ink and containing cabozantinib ( S )-malate salt equivalent to 20 mg cabozantinib.
COMETRIQ 80 mg capsules are supplied as hard gelatin capsules with Swedish orange cap and Swedish orange body, printed with “XL184 80mg” in black ink and containing cabozantinib ( S )- malate salt equivalent to 80 mg cabozantinib.

Store COMETRIQ at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F)