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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