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%.

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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%.

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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.

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