Dr. Edward B. Garon: June 24, 2020

NEW TREATMENT OPTION FOR PATIENTS LIVING WITH FORM OF METASTATIC NON-SMALL CELL LUNG CANCER

FDA approves Tabrecta™ for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14)

Dr. Edward B. Garon, MD

Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center

 

Lung cancer is the leading cause of cancer deaths in the United States. It claims more lives each year than colon, prostate, ovarian and breast cancers combined.1

 

Non-small cell lung cancer (NSCLC), accounts for approximately 85% of new lung cancer diagnoses each year worldwide, including 228,000 in the United States.1 A complex disease, NSCLC could have many different types of mutations that may promote the cancer’s growth. In fact, nearly 70% of NSCLC patients have an identifiable genomic mutation driving their cancer,2 such as the aggressive MET exon 14 skipping (METex14), observed in approximately 3% to 4% of newly diagnosed metastatic NSCLC cases (about 4,000 – 5,000 patients in the US annually).3,4 These patients may face poor prognosis due to the presence of METex14. So it is important for patients to speak with their doctor at the time of diagnosis and when their disease progresses to determine their mutational status.

 

Until recently, patients with mNSCLC with METex14 have not had a treatment option approved to specifically target the driver of their NSCLC. The U.S. Food and Drug Administration has now approved Tabrecta™ (capmatinib) tablets, for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14, as detected by an FDA-approved test.This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

 

This approval fills a long-recognized and urgent need among patients with METex14. Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type, and is now available to patients.

 

On June 24, 2020, Dr. Edward B. Garon will be available for interviews. He will discuss the recent FDA approval, why this new treatment is so meaningful and the latest statistics on lung cancer.

 

For more information please visit: www.tabrecta.com

 

More About (Talent):

Dr. Edward B. Garon, Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center, received his MD degree from the Washington University School of Medicine in 1999, and his internal medicine training at the University of Chicago. He trained in Medical Oncology at UCLA, and joined the UCLA faculty in 2006. In 2008, he was appointed as an Assistant Professor of Medicine at the Geffen School of Medicine at UCLA in the Department of Medicine, Division of Hematology/Oncology and in 2014 he was promoted to Associate Professor of Medicine. In addition to his clinical work, he also has an extensive focus in clinical and translational research. He has led studies that have led to FDA approvals of two drugs and a companion diagnostic test. 

 

Indication

TABRECTA™ (capmatinib) tablets is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery (metastatic), and whose tumors have an abnormal mesenchymal-epithelial transition (MET) gene.

 

The effectiveness of TABRECTA in these patients is based on a study that measured 2 types of response to treatment (response rate and duration of response). There is no clinical information available to show if patients treated with TABRECTA live longer or if their symptoms improve. There are ongoing studies to find out how TABRECTA works over a longer period of time.

 

It is not known if TABRECTA is safe and effective in children.

 

Important Safety Information

TABRECTA may cause serious side effects, such as lung or breathing problems. TABRECTA may cause inflammation of the lungs during treatment that may lead to death. Patients should be advised to contact their health care provider right away if they develop any new or worsening symptoms, including cough, fever, trouble breathing, or shortness of breath.

 

TABRECTA may cause abnormal blood test results, which may be a sign of liver problems. Patients should be advised that their health care provider will do blood tests to check their liver before starting and during treatment with TABRECTA. Patients should be advised to contact their health care provider right away if they develop any signs and symptoms of liver problems including the skin or the white part of their eyes turning yellow (jaundice), dark or “tea-colored” urine, light-colored stools (bowel movements), confusion, loss of appetite for several days or longer, nausea and vomiting, pain, aching, or tenderness on the right side of the stomach area (abdomen), or weakness or swelling in the stomach area.

 

The skin may be sensitive to the sun (photosensitivity) during treatment with TABRECTA. Patients should be advised to use sunscreen or wear clothes that cover their skin during treatment with TABRECTA to limit direct sunlight exposure.

 

For women of reproductive potential, TABRECTA can harm their unborn baby. They should use an effective method of birth control during treatment with TABRECTA and for 1 week after the last dose.

 

Men who have partners who can become pregnant should use effective birth control during treatment with TABRECTA and for 1 week after the last dose.

 

Before taking TABRECTA, patients should tell their health care provider about all their medical conditions, including if they have or have had lung or breathing problems other than lung cancer, have or have had liver problems, or if they are pregnant or plan to become pregnant, as TABRECTA can harm their unborn babies. Females who are able to become pregnant should have a pregnancy test before they start treatment with TABRECTA and should use effective birth control during treatment and for 1 week after the last dose of TABRECTA. Patients should be advised to talk to their health care provider about birth control choices that might be right for them during this time and to tell their health care provider right away if they become pregnant or think they may be pregnant during treatment with TABRECTA. Males who have female partners who can become pregnant should use effective birth control during treatment and for 1 week after their last dose of TABRECTA.

 

Patients should tell their health care provider about all the medicines they take or start taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

The most common side effects of TABRECTA include swollen hands, ankles, or feet (peripheral edema); nausea and/or vomiting; tiredness and/or weakness (fatigue, asthenia); shortness of breath (dyspnea); loss of appetite; changes in bowel movements (diarrhea or constipation); cough; pain in the chest; fever (pyrexia); back pain; and decreased weight.

 

Produced for: Novartis

 

References                                               

1. World Health Organization. Cancer Fact Sheet, 2018. Available at: https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed December 13, 2019.

2. American Cancer Society. About Lung Cancer. Available at https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed December 13, 2019.

3. Hirsch FR, Suda K, Wiens J, et al. New and emerging targeted treatments in advanced non-small-cell lung cancer. Lancet. 2016;388:1012-1024.

4. Salgia R. MET in Lung Cancer: Biomarker Selection Based on Scientific Rationale. Mol Cancer Ther. 2017;16(4):555-565.

5. Tabrecta (capmatinib) Prescribing Information. East Hanover., New Jersey, USA: Novartis Pharmaceuticals Corporation; May 2020.

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