What is Gavreto (pralsetinib) used for?
Gavreto (pralsetinib) is a targeted cancer therapy classified as a kinase inhibitor. It is indicated for adult patients with:
- Metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
- Advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy, and who are refractory to radioactive iodine treatment (if applicable)
Gavreto is available in 100 mg oral capsules.
How does Gavreto (pralsetinib) work?
Pralsetinib inhibits the activity of the RET (REarranged during Transfection) tyrosine kinase, a protein involved in cell growth and survival. In certain cancers, the RET gene becomes fused with another gene, forming an abnormal fusion gene that causes uncontrolled cell growth.
By selectively targeting and inhibiting RET, pralsetinib helps halt tumor progression and promote cancer cell death.
Where has Gavreto been approved?
Gavreto (pralsetinib) has received approval from:
- U.S. Food and Drug Administration (FDA):
- For metastatic RET fusion-positive NSCLC (September 4, 2020)
- For RET-altered thyroid cancers (November 30, 2020)
- European Medicines Agency (EMA):
- For first-line treatment of RET fusion-positive advanced NSCLC
Gavreto received Breakthrough Therapy and Priority Review designations from the FDA, recognizing its potential benefit for patients with RET-driven cancers. It was also granted Orphan Drug designation for rare cancer types.
Note: Approvals may vary by country. Please consult with our support team for region-specific information.
How is Gavreto (pralsetinib) administered?
The recommended dosage is:
- 400 mg once daily, taken orally on an empty stomach (no food for at least 2 hours before and 1 hour after taking the medication)
Patient eligibility for Gavreto is determined based on detection of RET gene fusions or mutations in tumor tissue or blood samples. Dosage may be adjusted when used with certain other medications or in response to side effects.
For full dosing details, refer to the official prescribing information.
Important: Always consult your healthcare provider for personalized dosage recommendations.
What are the potential side effects of Gavreto?
Common side effects (≥20% of patients):
- Fatigue
- Constipation
- Muscle and joint pain
- High blood pressure
- Low white and red blood cell counts
- Low levels of phosphate, sodium, and calcium in the blood
- Elevated liver enzymes
Serious side effects:
- Lung inflammation
- Liver toxicity
- Hypertension
- Bleeding events
- Impaired wound healing
Use in special populations:
Gavreto may cause fetal harm and is not recommended during pregnancy or breastfeeding. It may also impact fertility in both men and women. Patients are advised to discuss family planning and reproductive health with their doctor prior to starting treatment.
For a complete list of potential side effects and risks, please consult the official prescribing information.
References
1. Full prescribing information [FDA]: Gavreto (pralsetinib) [PDF]
Roche, Sept 2020
2. RET fusion in advanced non-small-cell lung cancer and response to cabozantinib
Wang Y, Medicine (Baltimore), Jan 18, 2019
3. The Role of RET Rearrangements in Lung Cancer
Cure Today article, Aug 26, 2020
4. Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer
Roche press release, Sep 7, 2020
5. Blueprint Medicines Announces FDA Approval of GAVRETO™ (pralsetinib) for the Treatment of Patients with Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancer
Biospace news item, Dec 1, 2020
6. Gavreto wins conditional EU approval to treat form of lung cancer -Roche
Reuters.com, Nov 2021
