For US Healthcare Professionals

Prescribing Information

Newly diagnosed ALK+ mNSCLC

About the ALECENSA® (alectinib) study

How ALECENSA may help treat ALK+ mNSCLC in the body

Will my ALK+ mNSCLC spread to or grow in the brain?

Possible side effects of ALECENSA

ALECENSA was evaluated against crizotinib in a large study of newly diagnosed people with ALK+ mNSCLC

In this clinical study, ALECENSA was compared with crizotinib, which was the most commonly prescribed treatment for newly diagnosed people (people who hadn't been previously treated with an ALK inhibitor) with ALK+ mNSCLC. The study included people with and without ALK+ mNSCLC tumors that had spread to the brain at the start of study.

The effectiveness of ALECENSA was measured by 2 different groups of doctors. These groups of doctors are often used in clinical studies to make sure that there is a balanced review of results.

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  • One group are the Investigators, or INV. These are the doctors who treat and evaluate people in a study 
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  • Another group is an Independent Review Committee, or IRC. These doctors do not treat the people in a study but evaluate and verify the results objectively

The people in the study receiving ALECENSA and crizotinib were evaluated at 2 different time points.

  • The first assessment was performed as soon as results were available. These were the main results of the study and were used to support the approval of ALECENSA
  • Like in many other studies, people continued to be monitored for a follow-up assessment

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ALECENSA extended the median length of time people lived without ALK+ mNSCLC growing or spreading

At the first assessment, the IRC found that, on average, people on ALECENSA lived more than twice as long without their ALK+ mNSCLC growing or spreading compared to people taking crizotinib. At this time, the Investigators were still collecting data.

IRC First Assessment (Main Results): 25.7 months with ALECENSA, 10.4 months with crizotinib

The Investigators performed a follow-up assessment 10 months later once more data were available. The results from this assessment are from an exploratory analysis. This means that it was not specifically designed to find differences between ALECENSA and crizotinib. The Investigators found that the median time people taking ALECENSA lived without their disease spreading or growing was 34.8 months.

INV Follow-Up Assessment (Exploratory): 34.8 months with ALECENSA, 10.9 months with crizotinib

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ALECENSA was able to shrink the size of tumors in nearly 80% of people with ALK+ mNSCLC

At the first assessment, the IRC evaluated the ability of ALECENSA to shrink the size of tumors in people with ALK+ mNSCLC.

Nearly 8 out of 10 people taking ALECENSA had their ALK+ mNSCLC tumors shrink

It is important to know that a complete response does not mean the cancer has been cured. 

The results seen with crizotinib were similar to those seen with ALECENSA.

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Of the people with ALK+ mNSCLC who had a reduction in tumor size, a response to treatment for 6 months or longer was seen in:

  • 82% of people taking ALECENSA
  • 57% of people taking crizotinib

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Fewer people who took ALECENSA experienced their ALK+ mNSCLC spreading to or growing in the brain

In the first assessment, the IRC found that fewer people who took ALECENSA experienced their ALK+ mNSCLC growing in or spreading to the brain as the first place their cancer spread. This included 122 people with and 181 people without ALK+ mNSCLC tumors that had spread to the brain at the start of the study.

12% who took ALECENSA® (alectinib) vs. 45% who took crizotinib developed ALK+ mNSCLC-related brain tumors or had their brain tumors grow

In this first assessment, the IRC also separated people into 2 smaller groups as part of an exploratory analysis

In people without ALK+ mNSCLC-related brain tumors at the start of the study

7% who took ALECENSA (alectnib) vs. 38% who took crizotinib had ALK+ mNSCLC-related tumors spread to the brain as the first place their cancer spread in an exploratory analysis

In people with ALK+ mNSCLC-related brain tumors that were measurable on a
brain scan at the start of the study

19% who took ALECENSA® (alectinib) vs. 57% who took crizotinib had ALK+ mNSCLC-related tumors grow in the brain as the first place their cancer began growing again in an exploratory analysis

People in this study who did not have ALK+ mNSCLC grow or spread to the brain first may still have had their cancer spread to other parts of the body.

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ALECENSA was able to shrink the size of ALK+ mNSCLC tumors that had spread to the brain

At the first assessment, the IRC studied reduction in tumor size in people with ALK+ mNSCLC-related brain tumors that were visible on a brain scan at the start of the study, which was part of an exploratory analysis.

81% who took ALECENSA® (alectinib) had the size of their ALK+ mNSCLC-related brain tumors shrink
  • 38% had their tumors disappear completely, also called a complete response
  • 59% had their response last for more than 1 year
50% who took crizotinib had the size of their ALK+ mNSCLC-related brain tumors shrink
  • 5% had a complete response
  • 36% had their response last for more than 1 year

It is important to know that a complete response does not mean the cancer has been cured.

Learn more about the possible side effects of ALECENSA.

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Overall survival data

Overall survival is the length of time from the start of treatment for a disease that people are still alive.

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First assessment (main results to support the approval of ALECENSA):

Median overall survival was not reached for ALECENSA (meaning over half the patients were still alive at the time of the assessment).

Follow-up assessment (exploratory analysis conducted 5 years after the last patient started treatment):

Median overall survival was still not reached because 60% of patients are still alive.

The results from this follow-up assessment were not used to support ALECENSA’s approval and not specifically designed to find differences between ALECENSA and crizotinib.

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First assessment (main results to support the approval of ALECENSA):

Median overall survival was not reached for ALECENSA (meaning over half the patients were still alive at the time of the assessment).

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Follow-up assessment (exploratory analysis conducted 5 years after the last patient started treatment):

Median overall survival was still not reached because 60% of patients are still alive.

The results from this follow-up assessment were not used to support ALECENSA’s approval and not specifically designed to find differences between ALECENSA and crizotinib.

Many patients taking ALECENSA reached a 5-year milestone.

60% who took ALECENSA® (alectinib) vs. 48% who took crizotinib are still alive at 5 years

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Next: ALK+ mNSCLC After Crizotinib
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Important Safety Information & Indications

Who is ALECENSA for?

ALECENSA is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene:

  • to help prevent your lung cancer from coming back after your tumor has been removed by surgery (adjuvant), or
  • as treatment when your lung cancer has spread to other parts of your body (metastatic)

Your doctor will perform a test to make sure that ALECENSA is right for you. It is not known if ALECENSA is safe and effective in children.

What is the most important information I should know about ALECENSA?

Everyone reacts differently to treatment with ALECENSA. It’s important to know the most serious and most common side effects with ALECENSA.

Your doctor may lower the dose or stop treatment with ALECENSA if any side effects occur. Contact your doctor right away if you have any of the following side effects.

ALECENSA may cause serious side effects, including:

Liver problems (hepatotoxicity). Liver problems are common with ALECENSA and can be severe. Your doctor will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and as needed during treatment with ALECENSA to check your liver function. Tell your doctor right away if you get any of the following signs and symptoms:

  • feeling tired
  • feeling less hungry than usual
  • yellowing of your skin or the whites of your eyes
  • dark urine
  • itchy skin
  • nausea or vomiting
  • pain on the right side of your stomach area
  • bleeding or bruising more easily than normal

Lung problems. ALECENSA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.

Kidney problems. ALECENSA may cause severe kidney problems that can lead to death. Tell your doctor right away if you have a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet.

Slow heartbeat (bradycardia). ALECENSA may cause very slow heartbeats that can be severe. Your doctor will check your heart rate and blood pressure during treatment with ALECENSA. Tell your doctor right away if you feel dizzy, lightheaded, or if you faint during treatment with ALECENSA. Tell your doctor if you take any heart or blood pressure medicines.

Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with ALECENSA and can be severe. Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with ALECENSA. Tell your doctor right away if you have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take ALECENSA. If this happens, you may not have enough healthy red blood cells. Your doctor may temporarily stop ALECENSA and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your doctor may either restart you on ALECENSA at a lower dose when the hemolytic anemia goes away, or may stop your treatment with ALECENSA. Tell your doctor right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

What should I tell my doctor before taking ALECENSA?

Before you take ALECENSA, tell your doctor about all of your medical conditions, including if you:

  • have liver problems
  • have lung or breathing problems
  • have a slow heartbeat
  • are pregnant or plan to become pregnant. ALECENSA can harm your unborn baby.
    Females who are able to become pregnant:
    • Your doctor will do a test to see if you are pregnant before starting treatment with ALECENSA
    • You should use effective birth control (contraception) during treatment with ALECENSA and for 5 weeks after the last dose of ALECENSA
    • Tell your doctor right away if you become pregnant during treatment with ALECENSA or think you may be pregnant
    Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with ALECENSA and for 3 months after the last dose of ALECENSA
  • are breastfeeding or plan to breastfeed. It is not known if ALECENSA passes into your breast milk. Do not breastfeed during treatment with ALECENSA and for 1 week after the last dose of ALECENSA. Talk to your doctor about the best way to feed your baby during this time.

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking ALECENSA?

Avoid spending time in the sunlight during treatment with ALECENSA and for 7 days after the last dose of ALECENSA. Your skin may be sensitive to the sun (photosensitivity) and you may burn more easily and get severe sunburns. Use sun protecting measures, such as sunscreen and lip balm with an SPF 50 or greater to help protect against sunburn.

What are the possible side effects of ALECENSA?

The most common side effects of ALECENSA include:

  • constipation
  • tiredness
  • swelling in your hands, feet, ankles, face, and eyelids
  • rash
  • cough

These are not all of the possible side effects of ALECENSA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.