Johnson & Johnson's Chemotherapy-free Lung Cancer Treatment Rybrevant Plus Lazcluze Gets FDA Nod

(RTTNews) - Johnson & Johnson (JNJ) Tuesday said the Food and Drug Administration or FDA has approved Rybrevant plus Lazcluze, the first and only chemotherapy-free regimen for the first-line treatment of adults with non-small cell lung cancer (NSCLC) having epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

The FDA approval is based on positive results from the Phase 3 MARIPOSA study, which showed Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30 percent compared to AstraZeneca's osimertinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. Osimertinib with chemotherapy was already approved by the FDA for the treatment of EGFR-mutated non-small cell lung cancer.

Rybrevant in combination with chemotherapy is already approved for the first-line treatment of patients with NSCLC having EGFR exon 20 insertion mutations.