The FDA has approved
This approval, which is the second new indication for Rybrevant this year, marks the first chemotherapy-free regimen that shows superior progression-free survival compared to the current standard of care, AstraZeneca's Tagrisso (osimertinib).
The decision follows a priority review and is based on the phase 3 MARIPOSA study, which demonstrated that the combination reduced the risk of disease progression or death by 30% and extended the median duration of response by nine months compared to osimertinib.
This new treatment option targets both common EGFR mutations directly, utilizing rybrevant, an EGFR- and MET-directed bispecific antibody that engages the immune system, and lazcluze, a highly selective third-generation oral EGFR inhibitor. The new approval offers a targeted approach that aims to improve patient outcomes without the need for chemotherapy.
First granted accelerated approval in May 2021 following the outcomes of the phase 3 PAPILLON study, Rybrevant, in combination with chemotherapy, demonstrated a notable improvement in progression-free survival for patients with locally advanced or metastatic NSCLC that presents with EGFR exon 20 insertion mutations. The drug was given full approval in March 2024.
