Shots:

• The approval is based on P-III COSMIC-311 evaluating Cabometyx (60mg- qd) vs PBO in a ratio (2:1) in 258 patients aged ≥12yrs. with radioactive iodine-refractory DTC who progressed after up to two prior VEGFR-targeted therapies across 164 sites globally
• At a planned interim analysis- the therapy demonstrated the reduction in the risk of disease progression or death in the ITT population- median follow-up of 10.1mos.- m-PFS (11.0 vs 1.9mos.) as assessed by blinded IRC- discontinuation due to AEs in 5% of patients. The results will be presented at ESMO 2021
• The therapy has received BTD & PR from the FDA & is approved before the expected PDUFA date (Dec 04- 2021). The company holds the exclusive rights to develop and commercialize cabozantinib in the US

  | Ref: Businesswire | Image: Businesswire