Regeneron’s Libtayo (cemiplimab) Receives the MHLW’s Approval for Advanced or Recurrent Cervical Cancer in Japan
- The MHLW has granted marketing & manufacturing authorization for Libtayo as monotx. for cervical cancer whose disease progressed after CT
- The approval was based on the P-III trial (EMPOWER-Cervical 1) evaluating Libtayo vs CT in 608 patients across 14 countries, incl. Japan. The study is being conducted in collaboration with NRG Oncology-Japan, the GOG Foundation, Inc. & the ENGOT groups
- The results showed an improvement in OS, PFS & ORR. In the overall population & SCC histology, 31% & 27% reduction in risk of death & a longer m-OS (12.0 vs 8.5mos.) & (11.1 vs 8.8mos.), 25% reduction of risk in progressive disease in the overall population & ORR (16% vs 6%), immune-mediated AEs (21%) & permanent treatment discontinuation (4.6%)
Ref: Regeneron | Image: Regeneron
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at firstname.lastname@example.org.