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What is brigatinib, and what is it used for?

Brigatinib is an oral medication used to treat anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). Seri

Brigatinib is an oral medication used to treat anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in adults.

Cancers are caused by gene mutations that lead to uncontrolled growth and replication of abnormal cells that do not function normally and suppress the growth and activity of normal cells. Brigatinib is a small molecule targeted therapy drug that does not kill cancer cells, but specifically targets the abnormal cells and alters cell mechanisms to prevent the growth and spread of cancer.

Brigatinib works by inhibiting the activity of several proteins known as tyrosine kinases, including abnormal ALK fusion proteins that go out of control because of certain gene mutations and promote the growth and proliferation of cancer cells. Other tyrosine kinases that brigatinib inhibits include ROS1, insulin-like growth factor-1 receptor (IGF-1R), FMS-like tyrosine kinase 3 (FLT-3), and epidermal growth factor receptor (EGFR) deletion and point gene mutations.

ALK is an enzyme coded by the ALK gene which helps in the development of the fetal gastrointestinal and nervous systems. The ALK gene is normally turned off in the fetal stage, but in some people, it gets turned on later and fuses with other genes and generates abnormal ALK fusion proteins. ALK fusion proteins alter cell signaling and gene expression, which results in the proliferation and survival of tumor cells that express this protein. Brigatinib inhibits the activity of ALK and ALK-mediated activation of downstream signaling protein STAT3. Brigatinib targets cancer cells that express ALK fusion proteins, including EML4-ALK and 17 mutant forms associated with resistance to other ALK inhibitor drugs, including crizotinib. Brigatinib also inhibits other mutant proteins including EGFR-Del (E746-A750), ROS1-L2026M, FLT3-F691L, and FLT3-D835Y. Brigatinib is approved for use only in the treatment of NSCLCs that are positive for ALK fusion proteins as detected by an FDA-approved test.

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Alunbrig (Brigatinib) Approved for Metastatic NSCLC with ALK Mutation

As knowledge of lung cancer tumor cell biology has evolved, small-molecule drugs that target specific genetic mutations offer oncologists th

Lung cancer is one of the most common cancers in men and women, and is the leading cause of cancer-related mortality in the United States.1 According to the American Cancer Society, more than 155,000 Americans will die from lung cancer in 2017, representing approximately 25% of all cancer deaths.1 Non–small-cell lung cancer (NSCLC), the most common form of the disease, accounts for 80% to 85% of all lung cancer cases.2

As knowledge of lung cancer tumor cell biology has evolved, small-molecule drugs that target specific genetic mutations offer oncologists the opportunity to treat patients with NSCLC in a personalized fashion.3 Multiple driver oncogenes have been identified in lung cancer, including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and KRAS.

Among US patients with advanced NSCLC, approximately 10% have EGFR mutations,3 approximately 23% have KRAS mutations,4 and up to 13% have ALK mutations.5 By identifying these mutations, oncologists can determine which patients can benefit from available targeted therapies.

Crizotinib (XALKori) was the first tyrosine kinase inhibitor (TKI) and alectinib (Alecensa) was the second TKI approved by the US Food and Drug Administration (FDA) for patients with advanced ALK-positive NSCLC.6,7 Although many patients with ALK-rearranged NSCLC respond to a TKI, the resistance rate is high within 1 to 2 years.8 Unlike crizotinib, which does not cross into the brain to target tumors in the central nervous system (CNS),9 alectinib has been shown to have “an effect on tumors that have spread to the brain.”7 Still, additional treatment options for ALK inhibition are needed that can cross the blood–brain barrier.

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Alunbrig (brigatinib) for the Treatment of Non-Small Cell Lung Cancer

Alunbrig (brigatinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+)

Alunbrig (brigatinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

The drug was originally discovered by Ariad Pharmaceuticals, which was acquired by Takeda Pharmaceutical Company in February 2017.

Ariad Pharmaceuticals submitted the new drug application (NDA) for Alunbrig to the US Food and Drug Administration (FDA) in August 2016. It was accepted for review in October and the company was granted breakthrough therapy designation. Takeda received accelerated approval in April 2017.

The marketing authorisation application (MAA) for Alunbrig was submitted to the European Medicines Agency (EMA) in February 2017.

Non-small cell lung cancer causes

One of the most common forms of lung cancer, NSCLC occurs when lung cells become abnormal and begin to develop beyond control. In advanced stages, the disease spreads tumours to the brain, bones, adrenal glands, liver, and kidneys.

Smoking is considered to be the major risk factor associated with NSCLC. Symptoms include coughing, chest pain, coughing blood, loss of appetite, shortness of breath, and wheezing.

NSCLC accounts for approximately 85% of the estimated 222,500 new cases of lung cancer diagnosed per year in the US, according to the American Cancer Society’s estimates.

Alunbrig’s mechanism of action

Alunbrig contains a tyrosine kinase inhibitor, which works against multiple kinases including anaplastic lymphoma kinase (ALK), receptor tyrosine kinase, insulin-like growth factor-1 receptor (IGF-1R), and Fms related tyrosine kinase 3 (FLT-3).

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ALUNBRIG can cause serious side effects

Learn about the safety of ALUNBRIG® and its possible side effects. Please see Important Safety Information and full Prescribing Information.

Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

trouble breathing or shortness of breath

chest pain

cough with or without mucus

fever

High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.

Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with ALUNBRIG. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALUNBRIG. Tell your healthcare provider if you take any heart or blood pressure medicines.

Vision problems. ALUNBRIG may cause vision problems. Your healthcare provider may stop ALUNBRIG and refer you to an eye specialist if you develop severe vision problems during treatment with ALUNBRIG. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:

double vision

seeing flashes of light

blurry vision

light hurting your eyes

new or increased floaters

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