Approvals

Johnson & Johnson company Janssen-Cilag Interenational NV has announced news that the European Commission (EC) has approved a marketing authorisation for the combination of LASCLUZE (lazertinib) and RYBREVANT (amivantamab) for first-in-line treatment of adult patients with epidermal growth factor receptor (EGFR) mutations exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations in non-small cell lung cancer (NSCLC).

The decision comes from the results of phase 3 of the MARIPOSA study, which met its primary endpoint of progression-free survival. The study evaluated the effects of lazertinib in combination with amivantamab, compared to osimertinib, on patients who have metastatic or locally advanced NSCLC with EGFR ex19del or L858R substitution mutations. In early January, it was announced that the second primary endpoint, topline positive overall survival, was also met. These results are clinically meaningful, and have demonstrated a statistically significant improvement in overall survival in comparison to the current standard-of-care (osimertinib monotherapy) according to the press release. The median overall survival is now expected to exceed one year.

Henar Hevia PhD, senior director, EMEA Therapeutic Area Lead, Oncology, commented: “Currently, the five-year survival rate for patients with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors is less than 20%. Today’s approval marks an important moment in lung cancer care, bringing a new option to patients through a chemotherapy-free regimen, and potentially offering more time with their loved ones.”