Exelixis’ Cabometyx (cabozantinib) Receives the US FDA’s Approval for the Treatment of Locally Advanced or Metastatic Differentiated Thyroid Cancer

September 20, 2021 Auto Bot approval, Cabometyx, Exelixis, FDA, regulatory 0

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

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