Learn more about LORBRENA (lorlatinib) and understand how it works

WHAT IS LORBRENA?

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LORBRENA is a prescription medicine that is used to treat adults with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene and that has spread to other parts of your body.

LORBRENA is available in a 100-mg strength tablet and a 25-mg strength tablet.

HOW LORBRENA WORKS

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LORBRENA was designed to inhibit the ALK protein, including ALK that has become resistant to other ALK inhibitors. Inhibiting the ALK protein can help LORBRENA slow the growth or spread of ALK+ tumors that have spread to other parts of the body.

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How LORBRENA Works in the Brain

The brain is a common site where ALK+ NSCLC spreads (metastasizes). One reason treating brain metastases can be challenging is that the medicine must cross the blood-brain barrier. The blood-brain barrier is a naturally occurring network of blood and tissue that helps prevent harmful substances, like bacteria, from entering the brain. LORBRENA was specifically designed to cross the blood-brain barrier and has been shown to help shrink ALK+ NSCLC tumors that have spread to the brain.

UNDERSTANDING LORBRENA
CLINICAL TRIAL RESULTS

LORBRENA Clinical Trial Results in Newly Diagnosed Patients

LORBRENA was evaluated in a clinical trial of 296 patients with ALK+ NSCLC whose cancer had spread to other parts of the body, including the brain. LORBRENA was compared to crizotinib, which is a different treatment for ALK+ NSCLC. All of the patients included in this trial were newly diagnosed and had not taken any treatment for their cancer.

The primary endpoint of this trial was progression-free survival, which is the length of time patients are living without their tumors growing or spreading (“progressing”).


LORBRENA reduced the risk of cancer growing or spreading by 72% compared to crizotinib. After a median of 9.3 months, half of crizotinib patients were living without their tumors growing or spreading, and half were not. At the time of the analysis, more than half of LORBRENA patients were still living without their tumors progressing. Therefore, the median time point when half of patients were living without their tumors progressing is not yet known for LORBRENA. More time is needed to determine whether or not LORBRENA helps patients live longer.


This study also assessed the overall response rate. This measures tumor response to treatment, including tumor shrinkage, throughout the body or specifically within the brain. In this study, 76% of patients had their tumors shrink or disappear with LORBRENA.

In a clinical trial of newly diagnosed patients, 76% of patients had their tumors shrink or disappear with LORBRENA (lorlatinib) compared to 58% with crizotinib
  • 3% of patients taking LORBRENA had all signs of cancer completely disappear (known as a complete response, although this does not mean the cancer is cured) compared to 0% of patients taking crizotinib
  • 73% of patients taking LORBRENA had their tumors shrink (known as a partial response) compared to 58% of patients taking crizotinib

These responses were ongoing in the majority of patients taking LORBRENA and lasted at least 12 months in 70% of patients. In patients taking crizotinib, responses lasted for a median of 11 months, and lasted at least 12 months in 27% of patients.


In a smaller group of 17 patients who had measurable brain tumors,* 82% of patients had their brain tumors shrink or disappear with LORBRENA.

82% of newly diagnosed patients who had measurable brain tumors had their brain tumors shrink or disappear with LORBRENA (lorlatinib) compared to 23% with crizotinib
  • 12 out of 17, or 71%, of patients taking LORBRENA had their brain tumors completely disappear (known as a complete response), although this does not mean the cancer is cured), compared to 1 out of 13, or 8%, of patients taking crizotinib
  • 2 out of 17, or 12%, of patients taking LORBRENA had their brain tumors shrink (known as a partial response), compared to 2 out of 13, or 15%, of patients taking crizotinib

These responses lasted at least 12 months in 79% of patients treated with LORBRENA and 0% of patients treated with crizotinib.

*Of the 296 patients in the trial, 78 had brain tumors at the start of treatment, including 30 patients who had brain tumors at the start of treatment, that could be measured. Of those 30 patients, 17 were treated with LORBRENA.

LORBRENA Clinical Trial Results in Previously Treated Patients

LORBRENA was also evaluated in a clinical trial of 215 previously treated patients with ALK+ NSCLC that had spread to other parts of the body, including the brain, and whose tumors were no longer responding to certain other medicines for ALK+ NSCLC.


This study assessed the overall response rate in previously treated patients. In this study, nearly half of patients had their tumors shrink or disappear with LORBRENA.

A study of previously treated patients achieved a 48% overall response rate with LORBRENA (lorlatinib)
  • 4% of patients treated with LORBRENA had all signs of cancer completely disappear (known as a complete response, although this does not mean the cancer is cured)
  • 44% of patients treated with LORBRENA had their cancer shrink (known as a partial response)

These responses lasted for median of 12.5 months.


In a smaller group of 89 patients who had measurable brain tumors* that were no longer responding to certain other medicines for ALK+ NSCLC, 60% of patients had their brain tumors shrink or disappear with LORBRENA.

A group of patients who were no longer responding to certain other medicines for ALK positive NSCLC achieved a 60% overall response rate with LORBRENA
  • 19 out of 89, or 21%, of patients taking LORBRENA had their brain tumors completely disappear (known as a complete response, although this does not mean the cancer is cured)
  • 34 out of 89, or 38%, of patients taking LORBRENA had their brain tumors shrink (known as a partial response)

These responses lasted for median of 19.5 months.

*Of the 215 patients in the trial, 148 (69%) had brain tumors at the start of treatment, including 89 patients who had brain tumors that could be measured.

The median is the middle number in a set of numbers arranged from least to greatest. Half of patients are above and half are below this middle number.

The median is the middle number in a set of numbers arranged from least to greatest. Half of patients are above and half are below this middle number.

The median is the middle number in a set of numbers arranged from least to greatest. Half of patients are above and half are below this middle number.

The median is the middle number in a set of numbers arranged from least to greatest. Half of patients are above and half are below this middle number.

The median is the middle number in a set of numbers arranged from least to greatest. Half of patients are above and half are below this middle number.

HEAR A REAL PATIENT DISCUSS HER EXPERIENCE WITH LORBRENA

Hear from Gina, a real LORBRENA (lorlatinib) patient and her experience with LORBRENA

"I knew that LORBRENA was an option for me"

-Gina, LORBRENA patient

Watch Gina's story

Important Safety Information and Indications

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Important Safety Information
LORBRENA® (lorlatinib) may cause serious side effects, including:
  • Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORBRENA.
  • Central nervous system (CNS) effects. LORBRENA may cause CNS effects, including problems with thinking (such as forgetfulness or confusion), changes in mood (such as depression and thoughts about suicide or dying), psychotic effects such as seeing or hearing things that are not real (hallucinations), seizures, changes in speech and changes in sleep. Tell your healthcare provider if you experience new or worsening symptoms of CNS effects.
  • Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most people will have an increase in the lipid levels in their blood during treatment with LORBRENA.
    • If you have increases in the lipid levels in your blood during treatment with LORBRENA, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine.
    • Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with LORBRENA.
  • Heart problems. LORBRENA may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram or EKG) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. In some people, these problems are severe, and your healthcare provider may need to have you stop taking LORBRENA or have a pacemaker placed.
  • Lung problems. LORBRENA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.
  • High blood pressure (hypertension). Your healthcare provider should check your blood pressure before starting treatment, 2 weeks after starting treatment, and then at least every month during treatment with LORBRENA. Your healthcare provider may need to start or change your blood pressure medicine if you have high blood pressure during treatment with LORBRENA. Tell your healthcare provider right away if you get signs or symptoms of high blood pressure, including headaches, dizziness, blurred vision, chest pain or shortness of breath.
  • High blood sugar (hyperglycemia). LORBRENA may increase your blood sugar levels. Your healthcare provider should do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of high blood sugar, including feeling very thirsty, needing to urinate more than usual, or feeling very hungry, sick to your stomach, weak or tired, or confused.

If you have serious side effects during treatment with LORBRENA, your healthcare provider may change your dose, stop your treatment for a period of time, or completely stop treatment with LORBRENA.

Before taking LORBRENA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems
  • have had episodes of depression or seizures
  • have high levels of cholesterol or triglycerides in your blood
  • have problems with your heartbeat
  • have lung or breathing problems
  • have high blood pressure
  • have diabetes or high blood sugar
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • Your healthcare provider will do a pregnancy test before you start treatment with LORBRENA.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LORBRENA.
      • Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA and for at least 6 months after the final dose of LORBRENA. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with LORBRENA. Talk to your healthcare provider about birth control choices that are right for you during this time.
      • Males who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA and for at least 3 months after the final dose of LORBRENA.
  • are breastfeeding or plan to breastfeed. It is not known if LORBRENA passes into your breast milk. Do not breastfeed during treatment with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. LORBRENA may affect the way other medicines work and other medicines may affect the way LORBRENA works, causing side effects.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Do not take LORBRENA if you take certain other medicines called strong CYP3A inducers. Ask your healthcare provider for a list of these medicines if you are not sure.

The most common side effects of LORBRENA include:

  • swelling in your arms, legs, hands, and feet (edema)
  • numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy)
  • weight gain
  • problems with thinking, such as forgetfulness or confusion
  • tiredness (fatigue)
  • difficulty breathing
  • pain in your joints
  • diarrhea
  • changes in mood, such as depression and irritability
  • high cholesterol and triglyceride levels in the blood
  • cough

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Indication

LORBRENA is a prescription medicine that is used to treat adults with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene and that has spread to other parts of your body.

Your healthcare provider will perform a test to make sure that LORBRENA is right for you.

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

Please see Full Prescribing Information and Patient Information.

Turn to Pfizer Oncology Together™ to learn about financial assistance resources and get personalized support from one of our dedicated Care Champions.Turn to Pfizer Oncology Together™ to learn about financial assistance resources and get personalized support from one of our dedicated Care Champions.

Copyright © 2021 Pfizer Inc. All rights reserved.

Patients should always ask their doctors for medical advice about adverse events.

You are encouraged to report an adverse event related to Pfizer products by calling 1-800-438-1985
(US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly.

The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

Pfizer, PO Box 29387, Mission, KS 66201.
Last Updated: April 2021 PP-LOR-USA-0320

LORBRENA® is a registered trademark of Pfizer Inc.