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How ALECENSA® (alectinib) may help

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Progression-free survival
Overall survival
Tumor response

Progression-free survival

A goal of treatment for metastatic cancer is to help people live longer without their disease getting worse. In the study, researchers used that measurement, also called median progression-free survival (mPFS), to see how ALECENSA worked when compared to another treatment called crizotinib.   

The mPFS for ALECENSA was over 2 years (25.7 months) compared to crizotinib, which was less than 1 year (10.4 months). This means that ALECENSA extended the median length of time people lived without their disease spreading or worsening by about 1 year and 3 months longer than crizotinib.

Exploratory follow-up assessment of the mPFS (10 months later)

The study also measured mPFS in a follow-up assessment.

There are limitations with these exploratory mPFS follow-up data. "Exploratory" is a way to describe data when the researchers do not make a formal comparison between 2 treatments. Your experiences may differ from the results. Talk to your doctor about how to best understand these results.

Overall survival

Researchers also looked at the effectiveness of ALECENSA by evaluating overall survival, or OS. This is the measurement of time after starting treatment during which a person is alive. At the first assessment (main results to support the approval of ALECENSA), median overall survival was not reached for ALECENSA. This means that over half of the people who were on ALECENSA were still alive at the time of the assessment. 

Exploratory follow-up assessment of the OS (5 years later)

The median overall survival was still not reached, because more than half of people on ALECENSA were still alive:

There are limitations with these exploratory OS follow-up data. "Exploratory" is a way to describe data when the researchers do not make a formal comparison between 2 treatments. Your experiences may differ from the results. Talk to your doctor about how to best understand these results.

Tumor response

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

The results seen with crizotinib were similar to those seen with ALECENSA (72% with crizotinib vs 79% with ALECENSA).

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  • Median progression-free survival (mPFS): A measurement of time after starting treatment when half of the people in the study are alive without the disease spreading or worsening.

  • Follow-up assessment: A type of assessment that looks at data that are collected after the main study period.

  • Overall survival: is the length of time from the start of treatment for a disease during which people are still alive.

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:

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

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

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