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# Rybrevant Hits Phase 3 Goals in Some Lung Cancers
- URL: https://www.fdaweb.com/rybrevant-hits-phase-3-goals-in-some-lung-cancers/
- Published: 2023-09-06T12:00:00.000Z
- Updated: 2026-09-14T18:54:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155256

Janssen says its Rybrevant (amivantamab-vmjw) met the MARIPOSA-2 dual primary endpoints, showing statistically significant and clinically meaningful improvement in progression-free survival plus chemotherapy with and without lazertinib (Janssen’s Leclaza) versus chemotherapy alone in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer after disease progression on AstraZeneca’s Tagrisso (osimertinib). A company [statement](https://www.prnewswire.com/news-releases/phase-3-mariposa-2-study-meets-dual-primary-endpoint-resulting-in-statistically-significant-and-clinically-meaningful-improvement-in-progression-free-survival-for-rybrevant-amivantamab-vmjw-plus-chemotherapy-with-and-without-la-301919084.html?ref=fdaweb.com) says MARIPOSA-2 is the first Phase 3 study to show statistically significant and clinically meaningful improvement in progression-free survival in the post-Tagrisso setting.

Rybrevant is described as a fully-human bispecific antibody targeting EGFR and mesenchymal epithelial transition with immune cell-directing activity. It received FDA accelerated approval in 5/2021 to treat adults with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.