NEW YORK - Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. In the U.S., BRAFTOVI + MEKTOVI is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

'For more than a decade, Pfizer Oncology has been at the forefront of bringing biomarker-driven treatment options to patients with cancer. Since their initial regulatory approvals, BRAFTOVI and MEKTOVI have helped improve outcomes in their respective indications of BRAF-mutated metastatic melanoma and BRAF-mutated metastatic colorectal cancer,' said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. 'Through our comprehensive development program, the BRAFTOVI and MEKTOVI combination has shown the potential to help more patients, such as those living with BRAF V600E-mutant non-small cell lung cancer. These sNDAs build on Pfizer's long heritage of meeting the diverse needs of people with NSCLC, and we look forward to working with the FDA on their review of these applications.'

These sNDAs are supported by results from the PHAROS trial (NCT03915951), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. PHAROS met its primary endpoint of objective response rate. Detailed results from the PHAROS study will be presented at an upcoming scientific congress.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the second most common type of cancer and the number one cause of cancer-related death around the world.1 In 2023, the American Cancer Society estimates there will be about 238,340 new cases of lung cancer diagnosed in the U.S.2 NSCLC accounts for approximately 80-85% of all lung cancers.3

Some lung cancers are linked to acquired genetic abnormalities. For instance, a BRAF V600E mutation occurs in approximately 2% of NSCLC cases4 and stimulates tumor cell growth and proliferation by altering the MAP kinase (MAPK) signaling pathway. Targeting components of this pathway could potentially inhibit unchecked tumor growth and proliferation caused by BRAF mutations.5

Precision medicine is increasingly being developed for NSCLC patients with genetic changes, such as BRAF mutations, that can be detected using biomarker tests.6,7 Advances in targeted therapy have been associated with significant improvements in population-level NSCLC mortality in recent years.8

About PHAROS

PHAROS (NCT03915951) is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in 98 patients with BRAF V600E-mutant metastatic NSCLC. The primary endpoint is objective response rate, based on independent radiologic review (per RECIST v1.1); secondary objectives will evaluate additional efficacy endpoints and safety. Duration of response is a key secondary endpoint. The trial is conducted across 53 sites in: Italy (5 sites), the Netherlands (2 sites), South Korea (3 sites), Spain (4 sites), and the U.S. (39 sites).

About BRAFTOVI + MEKTOVI

BRAFTOVI is an oral small molecule BRAF kinase inhibitor and MEKTOVI is an oral small molecule MEK inhibitor which target key proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of this pathway has been shown to occur in many cancers, including melanoma, CRC, and NSCLC.

In 2018, the FDA approved BRAFTOVI + MEKTOVI in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. The approval was based on COLUMBUS, a randomized, active-controlled, open-label, Phase 3 trial.

In 2020, BRAFTOVI was FDA-approved, in combination with cetuximab, for the treatment of adults with metastatic CRC with a BRAF V600E mutation, as detected by an FDA-approved test. The approval was based on results from the BEACON CRC trial.

Pfizer has exclusive rights to BRAFTOVI and MEKTOVI in the U.S., Canada, and all countries in the Latin America, Africa, and Middle East regions. Ono Pharmaceutical Co. Ltd. has exclusive rights to commercialize both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific (excluding Japan and South Korea).

About Pfizer Oncology

At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

About Pfizer: Breakthroughs That Change Patients' Lives

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, including innovative medicines and vaccines. 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 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.

DISCLOSURE NOTICE

The information contained in this release is as of April 4, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a potential new indication for BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation (the 'potential indication'), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; uncertainties regarding the commercial success of BRAFTOVIand MEKTOVI; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications for the potential indication may be filed with regulatory authorities in any other jurisdictions; whether and when the FDA will approve the sNDAs for the potential indication and whether and when regulatory authorities in any jurisdictions may approve any such applications that may be pending or filed for BRAFTOVI and MEKTOVI, which will depend on myriad factors, including making a determination as to whether the products' benefits outweigh their known risks and determination of the products' efficacy and, if approved, whether BRAFTOVIand MEKTOVI will be commercially successful; decisions by regulatory authorities regarding labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BRAFTOVI and MEKTOVI, including the potential indication; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results and competitive developments.

Contact:

Tel: +1 (212) 733-1226

Email: PfizerMediaRelations@Pfizer.com

(C) 2023 Electronic News Publishing, source ENP Newswire