Janssen Reports the sBLA Submission of Rybrevant to the US FDA as 1L Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Shots:
- The company submitted the sBLA to the US FDA seeking the expanded approval of Rybrevant + CT (carboplatin-pemetrexed) as 1L treatment of patients with LA or metastatic NSCLC with EGFR exon 20 insertion mutations
- The sBLA was based on the P-III trial (PAPILLON) results evaluating Rybrevant + CT vs CT alone in 308 patients. The study met its 1EPs with an improvement in PFS & demonstrated a safety profile consistent with the safety profiles of the individual components
- Rybrevant received accelerated approval from the US FDA in May 2021 for LA or metastatic NSCLC with EGFR exon 20 insertion mutations & received approval from health authorities in the EU & other markets globally. The therapy is also being evaluated in multiple clinical trials in NSCLC
Ref: PRNewswire | Image: Janssen
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