This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2023
  • /
  • 5
  • /
  • First-line Libtayo plus chemotherapy receives appr...

First-line Libtayo plus chemotherapy receives approval in Canada for advanced NSCLC.- Regeneron

Read time: 1 mins
Published:12th May 2023

The regulatory decision was supported by data from the phase III EMPOWER-Lung 3 trial (Study 16113; NCT03409614), which showed that cemiplimab plus chemotherapy provided a statistically significant and clinically meaningful improvement in overall survival (OS) vs placebo plus chemotherapy (HR, 0.71; 95% CI, 0.53-0.93; 2-sided P = .0140). Patients treated in the cemiplimab arm (n = 312) experienced a median OS of 21.9 months (95% CI, 15.5-not evaluable) compared with 13.0 months (95% CI, 11.9-16.1) for those in the placebo arm (n = 154).

“The approval of this new indication of [cemiplimab] highlights continued progress in first-line treatment options for people impacted by advanced lung cancer in Canada,” Barb Melosky, MD, FRCPC, clinical professor of medicine at the University of British Columbia, stated in a news release. “The phase III EMPOWER-Lung 3 trial showed significant improvements across primary and key secondary end points, including OS in the cemiplimab plus chemotherapy arm.”

On 8 November 2022, the FDA approved cemiplimab in combination with platinum-based chemotherapy for the treatment of adult patients with advanced NSCLC with no EGFR, ALK, or ROS1 aberrations, based on data from EMPOWER-Lung 3.

Condition: Non Small Cell Lung Cancer
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.