What were the results for GAVRETO in a RET+ mNSCLC study?

GAVRETO was studied to see if it was safe and effective in treating adults with RET+ metastatic non–small cell lung cancer (mNSCLC)

Clinical study background for GAVRETO:

What was measured in the clinical study?

  • How many adults had their tumors shrink by at least 30% (a partial response) or completely disappear (a complete response)*
  • How long their response to treatment lasted

*It is important to know that a complete response (which means all tumors have responded and completely disappeared) does not mean the cancer has been cured.

Who was included in the clinical study?

237 adults with RET+ mNSCLC, including:

iv bag x

107 adults who never had cancer treatment before

iv bag 1

130 adults who had at least 1 cancer treatment in the past

of those 130 adults,

Brain tumors

10 adults had tumors that spread to the brain. None had received radiation therapy within 2 months before the start of the study.

RET+=rearranged during transfection positive.

GAVRETO was effective in treating adults with RET+ mNSCLC

GAVRETO was approved based on the results shown below

iv bag x

In 107 adults who had never received cancer treatment before GAVRETO:

78%

saw their tumors shrink or disappear*

(83 out of 107 adults)

78 percent shrunk

And of those adults who had tumor shrinkage, 45% (37 out of 83 adults) saw their response to treatment last for up to 12 months or longer.

*It is important to know that a complete response (which means all tumors have responded and completely disappeared) does not mean the cancer has been cured.

iv bag 1

In 130 adults who had received cancer treatment before GAVRETO†:

63%

saw their tumors shrink*

(82 out of 130 adults)

63 percent shrunk

And of those adults who had tumor shrinkage, 66% (54 out of 82 adults) saw their response to treatment last for up to 12 months or longer.

*It is important to know that a complete response (which means all tumors have responded and completely disappeared) does not mean the cancer has been cured.
†Treatments received by patients before GAVRETO included chemotherapy, immunotherapy, multikinase inhibitors, or other systemic therapies.

Brain tumors

In 10 adults who had received cancer treatment before GAVRETO and had tumors that spread to the brain:

70%

saw their brain tumors shrink*

(7 out of 10 adults)

Among the 130 adults with RET+ mNSCLC who had cancer treatment in the past and received GAVRETO during the clinical study, 10 adults had tumors that spread to the brain before the study. No one received radiation therapy to the brain within 2 months before participating in the clinical study.

And of those adults who had tumor shrinkage, 71% (5 out of 7 adults) saw their response to treatment last for up to 6 months or longer.

Please note that these results were only observed in a limited number of patients.

*It is important to know that a complete response (which means all tumors have responded and completely disappeared) does not mean the cancer has been cured.

NEXT: GAVRETO Side Effects
Side Effects
Everyone responds to treatment differently

It is helpful to know what side effects you might experience.

See possible side effects

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Indications & Important Safety Information

WHAT IS GAVRETO?

GAVRETO is a prescription medicine used to treat certain cancers caused by abnormal rearranged during transfection (RET) genes in:

  • adults with non-small cell lung cancer (NSCLC) that has spread
  • adults and children 12 years of age and older with advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working*

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

It is not known if GAVRETO is safe and effective when used to treat cancers caused by abnormal RET genes in children for the treatment of NSCLC or in children younger than 12 years of age for the treatment of thyroid cancer.

*GAVRETO was approved 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 GAVRETO.

IMPORTANT SAFETY INFORMATION

GAVRETO may cause serious side effects, including:

Lung problems: GAVRETO may cause severe or life-threatening inflammation of the lungs during treatment, that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including shortness of breath, cough, or fever.

High blood pressure (hypertension): High blood pressure is common with GAVRETO and may sometimes be severe. You should check your blood pressure regularly during treatment with GAVRETO. Tell your healthcare provider if you have increased blood pressure readings or get any symptoms of high blood pressure, including confusion, dizziness, headaches, chest pain or shortness of breath.

Liver problems: Liver problems (increased liver function blood test results) can happen during treatment with GAVRETO and may sometimes be serious. Your healthcare provider will do blood tests before and during treatment with GAVRETO to check you for liver problems. Tell your healthcare provider right away if you get any signs or symptoms of liver problem during treatment, including yellowing of your skin or the white part of your eyes (jaundice), loss of appetite, nausea or vomiting, dark “tea-colored” urine, pain on the upper right side of your stomach area, sleepiness, bleeding or bruising.

Bleeding problems: GAVRETO can cause bleeding which can be serious and cause death. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment, including vomiting blood or if your vomit looks like coffee grounds, unusual vaginal bleeding, nose bleeds that happen often, pink or brown urine, drowsiness or difficulty being awakened, red or black (looks like tar) stools, confusion, coughing up blood or blood clots, headache, unusual bleeding or bruising of your skin, change in speech, or menstrual bleeding that is heavier than normal.

Tumor lysis syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment, an abnormal heartbeat, and may sometimes lead to hospitalization. Your healthcare provider may do blood tests to check you for TLS. You should stay well hydrated during treatment with GAVRETO. Call your healthcare provider or get emergency medical help right away if you develop any of these symptoms during treatment with GAVRETO: nausea, shortness of breath, vomiting, muscle cramps, weakness, seizures or swelling.

Risk of wound healing problems: Wounds may not heal properly during treatment with GAVRETO. Tell your healthcare provider if you plan to have any surgery before or during treatment with GAVRETO. You should not take GAVRETO for at least 5 days before surgery. Your healthcare provider should tell you when you may start taking GAVRETO again after surgery.

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

  • have lung or breathing problems other than lung cancer
  • have high blood pressure
  • have bleeding problems
  • have liver problems
  • plan to have surgery
  • are pregnant or plan to become pregnant. GAVRETO can harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider will do a pregnancy test before you start GAVRETO.
    • Should use an effective form of non-hormonal birth control (contraception) during treatment with GAVRETO and for 2 weeks after your last dose of GAVRETO.
    • Birth control methods that contain hormones (such as birth control pills, injections or transdermal system patches) may not work as well during treatment with GAVRETO.
    • Talk to your healthcare provider about birth control methods that may be right for you during this time.
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with GAVRETO.

    Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 1 week after your last dose of GAVRETO.

  • are breastfeeding or plan to breastfeed. It is not known if GAVRETO passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of GAVRETO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking GAVRETO with other medicines may affect how GAVRETO works.

The most common side effects of GAVRETO include: muscle and joint pain, constipation, diarrhea, tiredness, swelling of your face, arms, legs, hands, and feet (edema), fever, and cough.

The most common severe abnormal blood test results with GAVRETO include: decreased white blood cell, red blood cell, and platelet counts, decreased levels of phosphate, body salt (sodium), calcium and potassium, abnormal liver function, increased levels of enzyme called alkaline phosphatase, and increased levels of potassium.

GAVRETO may affect fertility in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of GAVRETO. 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.

Click here for full Prescribing Information, including Patient Information.