Johnson & Johnson (NYSE:JNJ) announced Tuesday that it has received U.S. Food and Drug Administration (FDA) approval for a combination treatment of RYBREVANT and LAZCLUZE for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations.
According to the company, it marks a breakthrough in lung cancer treatment, as it is the first and only multitargeted, chemotherapy-free combination regimen approved for this patient population.
The combination therapy is said to have demonstrated superior efficacy in reducing the risk of disease progression or death compared to the current standard of care, osimertinib, in the Phase 3 MARIPOSA study.
Lung cancer remains a leading cause of cancer mortality worldwide, with NSCLC accounting for the majority of cases.
"Today's FDA approval of chemotherapy-free RYBREVANT plus LAZCLUZE in the first line is an incredible step towards our goal of altering the trajectory of lung cancer and reducing the impact of the world's leading cause of cancer mortality," said John Reed, Executive Vice President of Innovative Medicine R&D at Johnson & Johnson
JNJ said the combination therapy targets the EGFR mutations directly and has shown promising results in terms of progression-free survival and duration of response.
They added that the safety profile of RYBREVANT plus LAZCLUZE was consistent with the profiles of the individual treatments.