Gavreto™ (pralsetinib)

GavretoTM (pralsetinib) is a targeted therapy that is used to treat some adults with metastatic (has spread to other parts of the body) non-small cell lung cancer (NSCLC) that is positive for certain changes in a gene known as rearranged during transfection (RET). RET gene changes are found in about 1 to 2 percent of people with NSCLC. Pralsetinib may also be used to treat patients with certain forms of thyroid cancer.1,2

Another RET-targeted therapy drug

Pralsetinib is the second RET-targeted therapy drug available in the United States. The other drug is RetevmoTM (selpercatinib). Having another drug available gives people with NSCLC more potential treatment options.1

The U.S. Food and Drug Administration (FDA) granted pralsetinib accelerated approval. This is given to new drugs that are very promising and could impact the treatment of a serious condition. This helps drugs like pralsetinib become available sooner. Continued approval of pralsetinib may depend on the results of more clinical trials to confirm the benefit of the medication.1

How does pralsetinib work?

Pralsetinib is a kinase inhibitor. This is a type of drug that blocks proteins that are found in some kinds of cancer cells. Blocking these proteins may slow or stop the growth of cancer cells. In people with NSCLC, pralsetinib targets and blocks the RET protein.1-3

What are the possible side effects of pralsetinib?

The most common side effects of pralsetinib include:3

  • Fatigue
  • Constipation
  • Muscle and joint pain
  • High blood pressure
  • Lowered white blood cell and red blood cell counts
  • Lowered levels of phosphate in the blood
  • Decreased sodium or calcium levels in the blood
  • Abnormal liver function tests
  • Lowered amounts of platelets (can increase the risk of bleeding and bruising)
  • Diarrhea

Other possible less common, but serious, side effects include:3

  • Lung problems, including shortness of breath and cough
  • High blood pressure leading to headaches, confusion, or shortness of breath
  • Liver problems, including yellowing of skin or eyes, dark urine, abdominal pain, and vomiting
  • Bleeding problems like blood in the urine, coughing up blood, unusual bleeding, tarry stools, and vaginal bleeding
  • Wound healing problems

These are not all the possible side effects of pralsetinib. Talk to your doctor about what to expect or if you experience any changes that worry you.

Things to know about pralsetinib

If you plan to have surgery while taking pralsetinib, let your doctor know ahead of time. Your doctor should instruct you on any potential adjustments to your treatment regimen prior to the procedure.3

Before starting treatment with pralsetinib, tell your doctor about all your health conditions, including if you have lung or breathing problems outside of cancer. Let your doctor know if you have high blood pressure or bleeding problems/disorders.3

If you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed, talk with your doctor. Pralsetinib can cause harm to a developing fetus and should not be taken by women who are pregnant. While taking pralsetinib, males with female partners who can become pregnant, and females who can become pregnant, should both use contraceptives during treatment and for a period of time after completing treatment (patients should discuss appropriate birth control methods, and how long they need to use them, with their doctor). Females should not breastfeed during pralsetinib treatment and for a period of time following the final dose (patients should discuss breastfeeding considerations with their doctor).3

Before beginning treatment with pralsetinib, patients should talk to their doctor about all medications (prescription and over-the-counter), vitamins, and supplements they are taking. Some medications or supplements may interfere with each other or cause unsafe side effects. Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their pralsetinib regimen.

For more information, read the full prescribing information of pralsetinib.

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Last reviewed: May 2021.