Aug. 21, 2024 – The FDA has approved a new initial treatment for advanced non-small-cell lung cancer after clinical trials showed patients lived longer without disease progression, compared to the standard treatment currently used.
The chemotherapy-free combination involves two drugs, one of which has never been approved for use in the U.S. called lazertinib, which will be marketed under the brand name Lazcluze. The other half is the drug amivantamab-vmjw, which is marketed under the brand name Rybrevant. Rybrevant was approved by the FDA in 2021.
The new combined Lazcluze-Rybrevant therapy is now FDA-approved for adults with certain types of non-small-cell lung cancer that has progressed to stage III or stage IV, also called locally advanced and metastatic. Changes in a gene’s DNA sequence drive the transformation of healthy cells into cancerous ones, and this new treatment targets the most common of those mutations in non-small-cell lung cancer.
The approval comes after the publication of phase III clinical trial results in The New England Journal of Medicine in June, as well as results presented last year at a medical conference. In its approval announcement, the FDA said the combination of Lazcluze and Rybrevant showed a longer survival benefit, compared to the current first-line treatment, called osimertinib. The median time without the disease getting worse for patients on osimertinib was 16.6 months, compared to 23.7 months for patients who were given Lazcluze and Rybrevant.
“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib,” study author Alexander Spira, MD, PhD, director of the Virginia Cancer Specialists Research Institute, said in a news release from Johnson & Johnson, the parent company of Janssen Biotech, the maker of Lazcluze and Rybrevant.
As many as 200,000 people in the U.S. are diagnosed annually with non-small-cell lung cancer. The 5-year overall survival rate can reach 28% with current treatments. In its approval announcement for Lazcluze and Rybrevant, the FDA said it was too early to report overall survival rates for the new treatment combination, but “no trend towards a detriment was observed.”
The FDA considered Lazcluze and Rybrevant under its expedited review program called Project Orbis, along with international partners in Australia, Brazil, Canada, Switzerland, and the United Kingdom.
