FDA Grants Regular Approval to Pralsetinib for Non-Small Cell Lung Cancer With RET Gene Fusions

August 9, 2023

The Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Pralsetinib was previously granted accelerated approval for the NSCLC indication on Sept. 4, 2020, based on initial overall response rate (ORR) and duration of response (DOR) in 114 patients enrolled in the ARROW trial (NCT0337385), a multicenter, open-label, multi-cohort trial. The conversion to regular approval was based on data from an additional 123 patients and 25 months of additional follow-up to assess durability of response.

Efficacy was demonstrated in a total of 237 patients with locally advanced or metastatic RET fusion-positive NSCLC. Patients received pralsetinib until disease progression or unacceptable toxicity. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Pralsetinib may cause serious side effects. Call your doctor at once if you have:
• fever, chills;
• new or worsening cough, shortness of breath, or chest pain;
• severe headache, dizziness, confusion, trouble speaking;
• any wound that will not heal;
• unusual bleeding–bruising, nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding
that will not stop;
• signs of bleeding inside your body–weakness, drowsiness, pink or brown urine, bloody or tarry
stools, coughing up blood or vomit that looks like coffee grounds;
• low blood cell counts–fever, tiredness, sore throat, mouth sores, skin sores, pale
skin, cold hands and feet, feeling light-headed or short of breath; or
• liver problems–nausea, vomiting, loss of appetite, stomach pain (upper right side), tiredness,
dark urine, jaundice (yellowing of the skin or eyes).

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