NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of both drugs as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by specific epidermal growth factor receptor (EGFR) mutations.
This FDA approval positions the Rybrevant-Lazclude combination as the first and only multitargeted, chemotherapy-free regimen to demonstrate superior outcomes compared to AstraZeneca’s third-generation EGFR TKI, Tagrisso (osimertinib), in first-line NSCLC treatment. Rybrevant, which received its initial US approval in 2021 for second-line monotherapy of NSCLC with EGFR exon 20 insertion mutations, has now expanded its indication. The recent approval follows a successful Phase III MARIPOSA trial, which reported a 30% reduction in the risk of disease progression or death, along with a median progression-free survival (PFS) of 23.7 months compared to Tagrisso’s 16.6 months.
Lazclude, a third-generation EGFR inhibitor similar to Tagrisso, was in-licensed by J&J from Yuhan Corporation in 2018. This week’s approval marks Lazclude’s global debut, adding a new dimension to J&J’s oncology portfolio.
The MARIPOSA trial’s results were pivotal, showcasing not only the primary endpoint of PFS but also a significant improvement in the secondary endpoint of median duration of response (DOR), with the combination therapy achieving 25.8 months versus 16.7 months for Tagrisso.- Flcube.com
