Regeneron’s Libtayo (cemiplimab) Receives the MHLW’s Approval for Advanced or Recurrent Cervical Cancer in Japan
Shots:
- 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
Related Posts:- Regeneron’s Libtayo (cemiplimab) Receives EC’s Approval as the 2L Treatment of Recurrent or Metastatic Cervical Cancer
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