U.S. FDA has approved VIZIMPRO® (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer

Pfizer Inc. (NYSE:PFE) 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 Together^TM, which offers personalized patient support including financial assistance and additional resources to help them manage day-to-day life with their condition.

About VIZIMPRO® (dacomitinib)

VIZIMPRO is a kinase inhibitor indicated 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. VIZIMPRO was reviewed and approved under the FDA’s Priority Review program.

The recommended dose of VIZIMPRO is 45 mg taken orally, once daily, with or without food. If dose reduction is necessary, then the first dose reduction should be to 30 mg once daily and second dose reduction should be to 15 mg once daily.

In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative development agreement to conduct ARCHER 1050 across multiple sites. SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies. Under the terms of this agreement, SFJ Pharmaceuticals provided the funding and conducted the trial to generate the clinical data used to support this application. Pfizer retains all rights to commercialize VIZIMPRO globally.

About ARCHER 1050

The efficacy of VIZIMPRO was demonstrated in ARCHER 1050, a global Phase 3 head-to-head trial conducted in patients with unresectable, metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. A total of 452 patients were randomized 1:1 to VIZIMPRO 45mg (n=227) or gefitinib 250mg (n=225). Randomization was stratified by region and EGFR mutation status. The major efficacy outcome measure was PFS as determined by blinded IRC review, and additional efficacy outcomes included ORR, DoR and OS.

The hierarchical statistical testing order was PFS followed by ORR and then OS. No formal testing of OS was conducted since the formal comparison of ORR was not statistically significant.

About XALKORI® (crizotinib)

XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. XALKORI has received approval for patients with ALK-positive NSCLC in more than 90 countries including Australia, Canada, China, Japan, South Korea and the European Union. XALKORI is also approved for ROS1-positive NSCLC in more than 60 countries.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide.¹ NSCLC accounts for about 85 percent of lung cancer cases and remains difficult to treat, particularly in the metastatic setting.² Approximately 75 percent of NSCLC patients are diagnosed late with metastatic or advanced disease where the five-year survival rate is only five percent.^3,4,5

EGFR is a protein that helps cells grow and divide. When the EGFR gene is mutated it can cause the protein to be overactive resulting in cancer cells to form. EGFR mutations may occur in 10 to 35 percent of NSCLC tumors globally, and 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. The disease is associated with low survival rates and disease progression remains a challenge.^5,6

About Pfizer in Lung Cancer

Pfizer Oncology is committed to addressing the unmet needs of a broad range of patients with lung cancer, the leading cause of cancer-related death worldwide and a particularly difficult-to-treat disease. Pfizer strives to address the diverse and evolving needs of patients with non-small cell lung cancer (NSCLC) by developing efficacious and safe therapies, including biomarker-driven therapies and combinations with immuno-oncology (IO) agents. By combining leading scientific insights with a patient-centric approach, Pfizer is continually advancing its work to match the right patient with the right medicine at the right time. Through our research pipeline and collaboration efforts, we are committed to delivering renewed hope to patients living with NSCLC.

About Pfizer Oncology

At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference on the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 11 approved cancer medicines across 19 indications, including breast, prostate, kidney, lung and hematology. We also have one of the deepest oncology biosimilars pipelines, with two medicines approved globally and several assets in mid to late-stage development for the treatment of cancer or as supportive care. Pfizer Oncology is striving to change the trajectory of cancer.

Pfizer Inc: Working together for a healthier world ^®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

September 28, 2018

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