FDA Approves GAVRETO for Metastatic Rearranged During Transfection Fusion-Positive NSCLC

The U.S. Food and Drug Administration (FDA) approved GAVRETO (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Select patients for treatment with GAVRETO based on the presence of a RET gene fusion. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

The approved recommended dosage of GAVRETO (pralsetinib) is 400 mg orally once daily on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking GAVRETO). Continue treatment until disease progression or until unacceptable toxicity.

Additional information regarding dosage and administration as well as warnings and precautions about interstitial lung disease (ILD)/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, risk of impaired wound healing, and embryo-fetal toxicity can be found in the full prescribing information linked below. GAVRETO can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception.