The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb) is now the only fully registered first-line therapy for this specific indication in the United States, marking an upgrade from the accelerated approval received in 2021.
The FDA’s decision was based on a priority review of Phase III clinical data, which demonstrated that the combination therapy reduced the risk of disease progression or death by 61% compared to chemotherapy alone. Additionally, the therapy showed an improved objective response rate (ORR).
Furthermore, the National Comprehensive Cancer Network (NCCN), a US-based not-for-profit alliance of 33 leading cancer centers, has recommended Rybrevant plus chemotherapy as a preferred first-line therapy for NSCLC with EGFR exon 20 insertion mutations.- Flcube.com
