Johnson & Johnson Reports the US FDA’s Approval of Rybrevant Combined with Chemotherapy as a 1L Treatment of NSCLC with EGFR Exon 20 Insertion Mutations
Shots:
- The US FDA has approved J&J’s Rybrevant + CT (carboplatin-pemetrexed) as a 1L treatment for locally advanced/metastatic NSCLC with EGFR exon 20 insertion mutations, followed by the accelerated approval in May 2021
- The approval was supported by the P-III (PAPILLON) trial to determine the safety & efficacy of Rybrevant + CT vs CT alone in newly diagnosed advanced/metastatic NSCLC patients (n=308) with EGFR exon 20 insertion mutations
- The results revealed a 61% reduction in the risk of disease progression or death, mPFS of 11.4mos. vs 6.7mos. with an improved ORR & PFS. OS was immature during the analysis. Based on these results, the NCCN updated its guidelines, giving a category 1 recommendation to the combination as the preferred 1L treatment for the indication
Ref: Janssen | Image: Janssen
Related News:- Janssen Submits a Marketing Authorisation Application to the EMA for Lazertinib Plus Rybrevant to Treat Lung Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
