A New Targeted Therapy Option for Lung Cancer
The FDA adds a fifth molecularly targeted therapeutic option for the treatment of lung cancer driven by EGFR mutations.
The U.S. Food and Drug Administration (FDA) recently approved a new molecularly targeted therapeutic called dacomitinib (Vizimpro) for treating certain patients with the most common type of lung cancer, non-small cell lung cancer (NSCLC).
Dacomitinib is approved for use as an initial treatment only for patients with metastatic NSCLC that tests positive for certain mutations in the EGFR gene, either the EGFR exon 19 deletion or the exon 21 L858R mutation.
More than 1.75 million people around the world die from lung cancer each year, making it the most commonly diagnosed cancer globally. About 142,670 deaths will occur in the United States in 2019, according to data from the National Cancer Institute. These statistics highlight the need for new approaches to treating lung cancer.
Research has shown that mutations in the EGFR gene are one of the most common drivers of NSCLC. With the approval of dacomitinib, there are now five EGFR-targeted therapeutics approved for treating certain patients with NSCLC testing positive for EGFR mutations. The other four are afatinib (Gilotrif), erlotinib (Tarceva), gefitinib (Iressa), and osimertinib (Tagrisso).
The latest approval was based on results from the randomized, phase III ARCHER 1050 clinical trial, which were published in Lancet Oncology. In brief, dacomitinib significantly improved the time before disease progressed for patients compared with gefitinib. The median time before disease progressed was 14.7 months among those who received dacomitinib compared with 9.2 months for those who received gefitinib. The approval was granted even though the researchers did not find any improvement in overall survival.
The FDA approval was rendered on Sept. 27, 2018.