EU approves J&J’s injectable Rybrevant with Yuhan’s Leclaza for lung cancer

2025-04-08 Kim Ji-hye

Johnson & Johnson (J&J) has secured E.U. approval for its subcutaneous (SC) formulation of Rybrevant (amivantamab), to be used in combination with Yuhan Corp.'s Leclaza (lazertinib, marketed as Lazcluze in Europe) as a first-line treatment for adults with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

Leclaza, developed by Korea’s Yuhan Corp. and marketed as Lazcluze in Europe, is now part of a newly approved first-line lung cancer treatment in the E.U. alongside Johnson & Johnson’s Rybrevant. (Courtesy of Yuhan Corp.)

The European Commission signed off Tuesday (local time) on SC amivantamab for two indications: in combo with lazertinib or EGFR exon 19 or 21-mutant NSCLC, and as a monotherapy for exon 20 insertion mutations after chemo. The green light follows a positive CHMP opinion in February.

The SC route slashes administration time to five minutes and cuts infusion-related reactions by 80 percent, according to phase 3 PALOMA-3 data. The IV version, by contrast, can take hours. The trial showed non-inferior pharmacokinetics and response rates—30 percent for SC vs. 33 percent for IV—plus a lower venous thromboembolism (VTE) rate (9 percent vs. 14 percent).

The final nod comes days after J&J dropped full OS data from the MARIPOSA study at ELCC, where IV Rybrevant plus lazertinib beat AstraZeneca’s Tagrisso (osimertinib) in newly diagnosed EGFR-mutant NSCLC, showing a 25 percent reduction in death risk (HR 0.75, p<0.005).

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