At the end of September, the FDA approved a once-per-day oral medication Vizimpro as a first-line treatment for patients with a rare form of lung cancer. Pfizer Pharmaceuticals will market the drug.
Vizimpro (dacomitinib), is approved to treat patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
The approval was obtained based on robust data from the Phase III ARCHER 1050 trial. In that study, patients were required to have unresectable, metastatic NSCLC with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. Trial data showed that patients treated with Vizimpro had a median progression-free survival of 14.7 months, compared to 9.2 months for the EGFR inhibitor gefitinib.
NSCLC accounts for about 85 percent of all global lung cancer cases. Of those patients, about 75 percent are diagnosed late with metastatic or advanced disease where the five-year survival rate is only 5 percent, Pfizer said. Some NSCLC patients experience mutations of the EGFR protein. It can help exacerbate the growth of cancer cells. Mutations in EGFR occur in 10 to 35 percent of NSCLC tumors. The most common activating mutations are deletions in exon 19 and exon 21 L858R substitutions, which together account for more than 80 percent of known activating EGFR mutations, Pfizer said. There are low survival rates for these patients.
Pfizer has shown a strong commitment to developing precision drugs to improve the outcomes of mutation-driven lung cancers, especially in lung cancer. The company should be applauded. The approval of Vizimpro marks the third FDA approved rare lung cancer drug they market.