The Food and Drug Administration (FDA) has approved Vizimpro (dacomitinib; Pfizer) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

The approval was based on data from the ARCHER 1050 open-label, active controlled study which randomized patients with unresectable, metastatic NSCLC to treatment with either dacomitinib (N=227) or gefitinib (N=225). 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; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; EGFR exon 19 deletion or exon 21 L858R substitution mutations. The major efficacy outcome measure was progression-free survival (PFS) as determined by blinded Independent Radiologic Central review.

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Results showed treatment with dacomitinib was associated with a statistically significant improvement in PFS compared with gefitinib (hazard ratio 0.59 [95% CI: 0.47, 0.74], P<.0001), however no significant improvements in overall response rate (75% for dacomitinib vs 72% for gefitinib; P=.39) or overall survival were observed. Median PFS in the dacomitinib group was 14.7 months vs 9.2 in the gefitinib arm.

“EGFR-mutated advanced non-small cell lung cancer is a common illness, especially in the Asian population, and new treatment options will ultimately benefit patients,” said Professor Tony Mok, MD, primary investigator for the ARCHER 1050 study and Chair of Department of Clinical Oncology, The Chinese University of Hong Kong. “The findings from ARCHER 1050 suggest that Vizimpro should be considered as a new first-line treatment option for patients with EGFR-mutated non-small cell lung cancer exon 19 deletion or exon 21 L858R substitution mutations.”

With regard to safety, the most common adverse reactions associated with dacomitnib treatment include diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

Vizimpro, a kinase inhibitor, will be supplied in 15mg, 30mg, and 45mg tablet strengths. It is expected to be available in mid-October 2018.

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