United States-based Exelixis has received approval from the United States Food and Drug Administration (FDA) for its CABOMETYX (cabozantinib) tablets intended for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib, it was reported yesterday.
The approval was based on results from the CELESTIAL phase three pivotal trial of CABOMETYX for patients with advanced HCC who received prior sorafenib. The product demonstrated a statistically significant and clinically meaningful improvement in overall survival versus placebo.
Michael M Morrissey, PhD, president and chief executive officer of Exelixis, said, 'This new indication for CABOMETYX is an important treatment advance for patients with this aggressive form of liver cancer, a community in need of new therapeutic options. This approval is an important milestone as we continue to explore how CABOMETYX may benefit people with difficult-to-treat-cancers beyond renal cell carcinoma. We would like to thank the patients and clinicians who participated in CELESTIAL and to acknowledge the team at the FDA for their continued collaboration during the review of our application.'
PepGen receives FDA designations for Duchenne muscular dystrophy therapy
Pfizer's PREVENAR 20 gains European Commission approval for paediatric pneumococcal vaccine
Astellas Pharma's CRESEMBA receives orphan drug and paediatric exclusivity from FDA
SK Biopharmaceuticals' cenobamate achieves 100,000 patient treatment milestone
Calliditas Therapeutics' Nefecon receives additional seven years orphan drug exclusivity from US FDA
Merck finalises acquisition of Harpoon Therapeutics Inc
RedHill Biopharma secures USPTO Patent for Talicia, extending protection through 2034
Celltrion USA submits CT-P39 Biologics License Application to FDA
iOnctura's first-in-class autotaxin cancer therapy granted US FDA Orphan Drug Designation
Epitomee submits Weight Loss Capsule for FDA approval in US
Calliditas Therapeutics TARPEYO receives seven years orphan drug exclusivity from US FDA
Camurus reports Oclaiz NDA accepted by FDA for acromegaly treatment
TME Pharma plans NOX-A12 Phase 2 trial in brain cancer after FDA IND clearance