HOW VITRAKVI^® CAN HELP

41 out of 55 patients had a response to treatment

A response* means that the cancer reduced in size and/or completely disappeared. Responses were analyzed across 3 clinical trials in 55 adults and children with TRK fusion cancer.

75% Response Rate

25%^† (14 patients) had a complete response, which means that their large tumors reduced in size and were able to be removed by surgery or disappeared completely

49% (27 patients) had a partial response, which means that their target tumors reduced in size by 30% or more

How long patients responded to treatment at time of analysis

In patients who had their tumors disappear or shrink, responses lasted for a median^‡ of 32.9 months, with a range of 1.6+ months and 50+ months^§
63% of patients had a response that lasted more than 12 months
49% of patients had a response that lasted more than 24 months
The median^‡ time it took patients to respond to treatment was less than 2 months^‖

*A response is a sum of partial response and complete response. Partial response is defined as a reduction in size of target tumors by 30% or more and complete response is defined as complete disappearance of all target tumors.

^†5% were patients who had a partial response and were able to have surgery to be disease free when the study data was analyzed.

^‡The median is the middle number in a group of numbers.

^§The duration of response is how long the response to treatment lasted.

^‖Range: 0.95 month to 14.55 months.

What is VITRAKVI?

VITRAKVI is a prescription medicine that is used to treat adults and children with solid tumors (cancer) that:

are caused by certain abnormal NTRK genes and
have spread or if surgery to remove their cancer is likely to cause severe complications, and
there is no acceptable treatment option or the cancer grew or spread on other treatment.

Your healthcare provider will perform a test to make sure that VITRAKVI is right for you.

It is not known if VITRAKVI is safe and effective in children younger than 28 days of age.

VITRAKVI was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of VITRAKVI for this use.

NTRK, neurotrophic receptor tyrosine kinase; TRK, tropomyosin receptor kinase.

Important Safety Information and Indication

VITRAKVI may cause serious side effects, including:

Central Nervous System (CNS) problems: VITRAKVI may cause dizziness, confusion, problems with concentration, attention, and memory, changes in your mood, and sleep problems. Tell your healthcare provider if you develop any of these symptoms or they get worse. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop central nervous system symptoms with VITRAKVI
Bone Fractures: Bone fractures can happen with VITRAKVI. Tell your healthcare provider if you develop pain, changes in ability to move around, or bone abnormalities
Liver problems. Increased liver enzymes in blood tests are common in people who take VITRAKVI. Increased liver enzymes can sometimes lead to liver problems which can become serious. Your healthcare provider will do blood tests to check your liver function every 2 weeks during the first month of treatment with VITRAKVI, then monthly, as needed. Tell your healthcare provider right away if you develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop liver problems with VITRAKVI

Before taking VITRAKVI, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have nervous system (neurological) problems
are pregnant or plan to become pregnant. VITRAKVI can harm your unborn baby. You should not become pregnant during treatment with VITRAKVI
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with VITRAKVI
- Females who are able to become pregnant should use effective birth control (contraception) during treatment and for at least 1 week after the final dose of VITRAKVI. Talk to your healthcare provider about birth control methods that may be right for you
- Males with female partners who are able to become pregnant should use effective birth control during treatment with VITRAKVI and for at least 1 week after the final dose of VITRAKVI
are breastfeeding or plan to breastfeed. It is not known if VITRAKVI passes into your breast milk. Do not breastfeed during treatment and for 1 week after the final dose of VITRAKVI
VITRAKVI may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you

While on VITRAKVI, you should avoid:

driving or operating machinery until you know how VITRAKVI affects you. VITRAKVI can make you feel dizzy
taking St. John's wort, eating grapefruit, or drinking grapefruit juice during treatment with VITRAKVI

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements. Certain other medicines may affect how VITRAKVI works and VITRAKVI may affect how other medicines work.

The most common side effects with VITRAKVI include:

low red blood cell and white blood cell counts
muscle and bone pain
tiredness
low levels of protein called albumin in the blood
increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems)
cough

constipation
diarrhea
dizziness
low levels of calcium in the blood
nausea
vomiting
fever
stomach (abdomen) pain

These are not all the possible side effects with VITRAKVI. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is VITRAKVI?

VITRAKVI is a prescription medicine that is used to treat adults and children with solid tumors (cancer) that:

are caused by certain abnormal NTRK genes and
have spread or if surgery to remove their cancer is likely to cause severe complications, and
there is no acceptable treatment option or the cancer grew or spread on other treatment.

Your healthcare provider will perform a test to make sure that VITRAKVI is right for you.

It is not known if VITRAKVI is safe and effective in children younger than 28 days of age.

VITRAKVI was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of VITRAKVI for this use.

NTRK, neurotrophic receptor tyrosine kinase; TRK, tropomyosin receptor kinase.

For important risk and use information about VITRAKVI, please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

For Bayer products, you can report these directly to Bayer by clicking here.

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Last updated on 04/2021