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.'
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML
Ligand Pharmaceuticals announces presentation of Captisol-enabled Topiramate Injection data