EC approves Rybrevant with Lazcluze for advanced lung cancer

New chemotherapy-free treatment shows promise for EGFR-mutated NSCLC

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission has approved Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) for first-line treatment of advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations.

This approval marks a significant milestone in the treatment of EGFR-mutated NSCLC.

“For people living with advanced NSCLC harbouring EGFR mutations, new treatment options are urgently needed,” said Dr Enriqueta Felip, head of the thoracic cancer unit at Vall d’Hebron University Hospital. “The combination of amivantamab and lazertinib has shown significant progression-free survival improvements, including for patients with brain metastases.”

Lung cancer is Europe’s biggest cancer killer, with NSCLC accounting for 85% of cases. EGFR mutation-positive NSCLC is a subtype based on specific mutations in the EGFR gene, with ex19del and exon 21 L858R being the most common.

Treatment resistance remains a challenge, highlighting the need for alternative therapies.

“This approval marks significant progress for those living with EGFR-mutated NSCLC, who often face poor prognosis,” said Dr Henar Hevia, Senior Director at Janssen. “The combination exemplifies targeted precision medicine, addressing the underlying genetic drivers and delaying the need for chemotherapy.”

The approval is based on the Phase 3 MARIPOSA study, which demonstrated that amivantamab plus lazertinib significantly reduced the risk of disease progression or death by 30% compared to osimertinib.

The median progression-free survival was 23.7 months for the combination therapy versus 16.6 months for osimertinib.

With this new approval, the combination of amivantamab and lazertinib offers a promising new standard of care for eligible patients in Europe.