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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 the 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 is being evaluated in a clinical trial. FDA approval for LORBRENA in newly diagnosed patients was based on an analysis of this trial at a median of 18 months of follow-up. These were the main results of the study. Patients in the trial were given one of two medicines, LORBRENA or crizotinib. Crizotinib is a different medicine for ALK+ NSCLC.
The main result of the study was progression-free survival (PFS).
PFS results from the trial were analyzed at a median of 18 months. At that time, LORBRENA had reduced the chances of tumor growth by 72% compared to crizotinib.
More than half of the patients taking LORBRENA had not experienced tumor growth at the analysis with 18 months of follow-up. Therefore, the medianprogression-free survival for LORBRENA had not been reached yet. Patients taking crizotinib experienced cancer progression at a median of 9 months.
More time is needed to find out if patients taking LORBRENA live longer than patients taking crizotinib.
The analysis at a median of 18 months of follow-up also evaluated the overall response rate. This measures tumor response to treatment, including tumor shrinkage and disappearance, throughout the body including the brain. 76% of patients had their tumors shrink or disappear while taking LORBRENA.
3% of patients taking LORBRENA had all signs of cancer disappear. This is known as a complete response. It does not mean the cancer is cured. 0% of patients taking crizotinib had all signs of cancer disappear.
73% of patients taking LORBRENA had their tumors shrink. This is known as a partial response. 58% of patients taking crizotinib had their tumors shrink.
These responses lasted 12 months or longer in 70% of patients taking LORBRENA. They lasted 12 months or longer in 27% of patients taking crizotinib.
30 patients had measurable brain tumors when the clinical trial began. 17 of these patients were treated with LORBRENA and 13 were treated with crizotinib.
12 out of 17, or 71%, of patients taking LORBRENA had their brain tumors disappear. This is known as a complete response. It does not mean the cancer is cured. 2 out of 17, or 12%, of patients taking LORBRENA had their brain tumors shrink. This is known as a partial response.
1 out of 13, or 8%, of patients taking crizotinib had their brain tumors disappear. 2 out of 13, or 15%, of patients taking crizotinib had their brain tumors shrink.
These responses lasted 12 months or longer in 79% of patients treated with LORBRENA and 0% of patients treated with crizotinib.
The patients in the clinical trial are still being monitored and data are being collected and evaluated. A follow-up analysis was done at a median of 5 years, once more data were available.
This informal analysis was performed at a median of 5 years of follow-up. It was not designed to find specific differences between LORBRENA and crizotinib. Unlike the main analysis, the data did not undergo an additional independent review, and it was not used to support the FDA approval of LORBRENA. The scientists, medical professionals, and the investigators assessed the informal analysis at 5-years of follow-up data. The following were observed:
No new safety concerns were detected in the follow-up analysis. The side effects experienced by patients in the main analysis were similar to those experienced in the follow-up analysis at a median of 5 years.
LORBRENA was also evaluated in a clinical trial of 215 previously treated patients. The patients had ALK+ NSCLC that had spread to other parts of the body, including the brain. Their tumors were no longer responding to certain other medicines for ALK+ NSCLC.
This trial assessed the overall response rate in previously treated patients. In this trial, nearly half of patients had their tumors shrink or disappear with LORBRENA.
These responses lasted for a median of 13 months.
A smaller group of 89 patients had measurable brain tumors* that were no longer responding to certain other medicines for ALK+ NSCLC. 60% of these patients had their brain tumors shrink or disappear with LORBRENA.
These responses lasted for a median of 20 months.
*Of the 215 patients in the trial, 148 (69%) had brain tumors at the start of treatment. 89 of the 148 patients had brain tumors that could be measured.
A statistics term. The median is the middle value in a set of measurements.
A statistics term. The median is the middle value in a set of measurements.
A statistics term. The median is the middle value in a set of measurements.
A statistics term. The median is the middle value in a set of measurements.
Progression-free survival is the length of time patients are living without their tumors growing or spreading (“progressing”).
A statistics term. The median is the middle value in a set of measurements.
Progression-free survival is the length of time patients are living without their tumors growing or spreading (“progressing”).
A statistics term. The median is the middle value in a set of measurements.
A statistics term. The median is the middle value in a set of measurements.
The overall response rate measures tumor response to treatment, including tumor shrinkage and disappearance, throughout the body, including the brain.
In a complete response, all signs of cancer disappear. It does not mean the cancer is cured.
In a partial response, a tumor shrinks in response to treatment.
A measurable tumor is one that can be accurately measured in size. This information can be used to judge response to treatment.
In a complete response, all signs of cancer disappear. It does not mean the cancer is cured.
In a partial response, a tumor shrinks in response to treatment.
A statistics term. The median is the middle value in a set of measurements.
A statistics term. The median is the middle value in a set of measurements.
Progression-free survival is the length of time patients are living without their tumors growing or spreading (“progressing”).
A statistics term. The median is the middle value in a set of measurements.
A statistics term. The median is the middle value in a set of measurements.
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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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