Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of 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.
"Improving outcomes for patients is the central focus of why we develop and deliver new medicines. VIZIMPRO is yet another example of Pfizer's commitment to providing more options in lung cancer where there is great unmet need," said Andy Schmeltz, Global President, Pfizer Oncology. "With today's approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach."
The safety and efficacy of VIZIMPRO was demonstrated in ARCHER 1050, a randomized, multicenter, multinational, open-label 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; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; EGFR exon 19 deletion or exon 21 L858R substitution mutations. A total of 452 patients were randomized 1:1 to VIZIMPRO (n=227) or gefitinib (n=225). The primary endpoint was progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review, and additional efficacy outcomes included overall response rate (ORR), duration of response (DoR) and overall survival (OS). A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to VIZIMPRO compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p <0.0001). Median PFS in the VIZIMPRO group was 14.7 months (95% CI: 11.1, 16.6) compared with 9.2 months (95% CI: 9.1, 11.0) 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."
Among 227 patients with EGFR-mutated metastatic NSCLC who received VIZIMPRO in ARCHER 1050, the most common (> 20%) adverse reactions were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%). Serious adverse reactions occurred in 27 percent of patients treated with VIZIMPRO. The most common (≥1%) serious adverse reactions reported were diarrhea (2.2%) and interstitial lung disease (1.3%). The full prescribing information for VIZIMPRO can be found here.
"Today's approval of VIZIMPRO is a direct result of our commitment to precision drug development and improving outcomes for patients with mutation-driven lung cancers. Pfizer now has two medicines that can tackle three different forms of mutation-driven lung cancer: XALKORI for patients with ALK-positive or ROS1-positive non-small cell lung cancer and VIZIMPRO for patients with EGFR-mutated non-small cell lung cancer," said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development.
Earlier this year, the FDA granted Priority Review for VIZIMPRO for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR-activating mutations. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists.
Pfizer is committed to ensuring that patients living with lung cancer have access to this innovative therapy. Patients in the U.S. who are prescribed VIZIMPRO have access to Pfizer Oncology TogetherTM, which offers personalized patient support including financial assistance and additional resources to help them manage day-to-day life with their condition.