August 21, 2024 – The FDA has approved a brand new first-line treatment for advanced non-small cell lung cancer after clinical trials showed patients lived longer without disease progression compared to plain treatment currently used.
The chemotherapy-free combination involves two drugs, one among which has never been approved within the United States: lazertinib, marketed under the brand name Lazcluze. The other half is the drug amivantamab-vmjw, marketed under the brand name Rybrevant. Rybrevant was approved by the FDA in 2021.
The recent Lazcluze-Rybrevant combination therapy is now approved by the FDA for adults with certain medical conditions non-small cell lung cancer that has progressed to stage III or IV, also called locally advanced and metastatic. Changes in a gene's DNA sequence drive the transformation of healthy cells into cancer cells, and this recent treatment targets probably the most common of those mutations in non-small cell lung cancer.
The approval comes after the publication of the outcomes of the phase III clinical trial The New England Journal of Medicine in June, in addition to results presented last 12 months at a medical conference. In its approval announcement, the FDA said the mix of Lazcluze and Rybrevant showed an extended survival profit in comparison with the present first-line treatment called osimertinib. The median time without disease worsening was 16.6 months in patients receiving osimertinib, in comparison with 23.7 months in patients receiving Lazcluze and Rybrevant.
“Patients now have the option of a potential new first-line treatment with significant clinical advantages over osimertinib,” said study creator Alexander Spira, MD, PhD, director of the Virginia Cancer Specialists Research Institute, in a Press release from Johnson & Johnson, the parent company of Janssen Biotech, the maker of Lazcluze and Rybrevant.
Up to 200,000 people within the United States are diagnosed with non-small cell lung cancer every year. The 5-year overall survival rate can reach 28% with current treatment methods. In its approval announcement for Lazcluze and Rybrevant, the FDA said it was too early to report overall survival rates for the brand new treatment combination but that “no trend toward impairment has been observed.”
The FDA reviewed Lazcluze and Rybrevant as a part of its accelerated review program called Project Orbis, together with international partners in Australia, Brazil, Canada, Switzerland and the United Kingdom.