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LORBRENA® (lorlatinib) 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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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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:
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:
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.
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.
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