Gavreto

PRALSETINIB

Manufacturer: Genentech, Inc.

Score: 141.0

Quick Summary

Gavreto (pralsetinib) is a kinase inhibitor used for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory. The recommended dosage is 400 mg orally once daily on an empty stomach. Important safety information includes warnings for interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, and tumor lysis syndrome. Contraindications and special population considerations, including use in pregnancy, pediatric use, and geriatric use, are also discussed.

Key Clinical Findings and Indications

Treatment of metastatic RET fusion-positive NSCLC
Treatment of advanced or metastatic RET fusion-positive thyroid cancer
Select patients for treatment based on the presence of a RET gene fusion

Important Safety Information

Warning

Gavreto can cause serious adverse reactions, including interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, and tumor lysis syndrome

Contraindications

None

Adverse Reactions

Musculoskeletal pain
Constipation
Hypertension
Diarrhea
Fatigue
Edema
Pyrexia
Cough

Dosing Recommendations

General Guidance

Reduce dose for adverse reactions, and consider dose modifications for use with CYP3A and/or P-gp inhibitors or inducers

Metastatic RET fusion-positive NSCLC

Adult Dose

400 mg orally once daily on an empty stomach

Pediatric Dose

Not established for pediatric patients with RET fusion-positive NSCLC

Advanced or metastatic RET fusion-positive thyroid cancer

Adult Dose

400 mg orally once daily on an empty stomach

Pediatric Dose

400 mg orally once daily on an empty stomach for pediatric patients 12 years of age and older

Special Population Considerations

Pregnancy

Gavreto can cause fetal harm when administered to a pregnant woman
Advise pregnant women of the potential risk to a fetus

Nursing Mothers

It is not known whether pralsetinib is present in human milk
Advise nursing mothers to discontinue breastfeeding during treatment with Gavreto

Pediatric Use

The safety and effectiveness of Gavreto have been established in pediatric patients aged 12 years and older for RET fusion-positive thyroid cancer
The safety and effectiveness of Gavreto have not been established in pediatric patients with RET fusion-positive NSCLC or in pediatric patients younger than 12 years old with RET fusion-positive thyroid cancer

Geriatric Use

No overall differences in pharmacokinetics, safety, or effectiveness were observed between patients aged 65 years or older and younger patients
Monitor growth plates in adolescent patients with open growth plates