Indication Tooltip

LORBRENA® (lorlatinib) is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

About
Lorbrena

What is Lorbrena?

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A Next-Generation Therapy

The ALK+ NSCLC treatment landscape is continuously evolving, and LORBRENA® is one of the latest ALK inhibitor therapies. It is a prescription medicine for people living with anaplastic lymphoma kinase (ALK)+ non-small cell lung cancer (NSCLC) that has spread to other parts of the body and their NSCLC is no longer responding to alectinib or ceritinib, or crizotinib and at least 1 other ALK inhibitor medicine.

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 other parts of the body, such as the brain.

 

Understanding LORBRENA Clinical Study Results

In a clinical study of 215 patients, LORBRENA was shown to be effective in treating some tumors that had already been treated with certain other medicines for ALK+ NSCLC.

Everyone in the study started on 100-mg LORBRENA tablets once daily.

The study assessed the Overall Response Rate (ORR). This measures tumor response to treatment, including tumor shrinkage, throughout the body or specifically within the brain.

LORBRENA was effective in treating ALK+ NSCLC that had spread to other parts of the body in patients whose tumors were no longer responding to alectinib or ceritinib, or crizotinib and at least 1 other ALK inhibitor medicine.

For the 215 patients enrolled in the study, 48% of them saw their tumors shrink while taking LORBRENA. This is known as Overall Response Rate (ORR), which measures tumor response to treatment, including if the tumor shrinks. Based on statistics, this number could be as low as 42% or as high as 55%.

48 percent orr graph

4% of patients had all signs of cancer disappear (known as a complete response, although this does not mean that the cancer is cured)

44% of patients had the spread of cancer lessened, or had tumors that shrank (known as a partial response)

LORBRENA was shown to be effective in treatment of ALK+ NSCLC that had spread to the brain.

For the 89 patients who began the study with NSCLC tumors that had already spread to the brain, the majority (60%) of patients saw the tumors in their brain shrink while taking LORBRENA. Based on statistics, this number could be as low as 49% or as high as 70%.

60 percent graph

21% of patients in this group had all signs of NSCLC tumors that had spread to the brain disappear (this does not mean cancer is cured)

38% of patients in this group had the spread of NSCLC tumors that had spread to the brain lessened, or had tumors that shrank

Over Time, LORBRENA Was Shown to Treat ALK+ NSCLC Tumors That Had Spread to Other Parts of the Body

The length of time these partial and complete responses lasted before the tumors resumed growing or spreading was a median time period Median time period: In a cancer treatment study, it often means that half of the patients responded to a treatment for at least a specific amount of time, and half responded for less than that specific amount of time. of 12.5 months.Median time period: In a cancer treatment study, it often means that half of the patients responded to a treatment for at least a specific amount of time, and half responded for less than that specific amount of time.

For patients who began the study with NSCLC tumors that had spread to the brain, the length of time these partial and complete brain responses lasted before the tumors resumed growing or spreading was a median time period Median time period: In a cancer treatment study, it often means that half of the patients responded to a treatment for at least a specific amount of time, and half responded for less than that specific amount of time. of 19.5 months.Median time period: In a cancer treatment study, it often means that half of the patients responded to a treatment for at least a specific amount of time, and half responded for less than that specific amount of time.

ALK=anaplastic lymphoma kinase; NSCLC=non-small cell lung cancer.

Important Safety Information and Indication

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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.
  • Problems with brain (central nervous system [CNS]) function. Many patients experience problems with brain function, including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.
  • Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most patients 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 [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. If these problems are severe, 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.

If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

  • are taking other medications
  • 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
  • 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.

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)
  • difficulty thinking or confusion
  • difficulty breathing
  • tiredness (fatigue)
  • weight gain
  • pain in your joints
  • changes in mood, feeling sad or anxious
  • diarrhea

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 healthcare provider 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 people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Please see Full Prescribing Information and Patient Information.

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