Gavreto Granted Full Approval for RET Fusion-Positive NSCLC

The US Food and Drug Administration (FDA) has granted full approval to Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

The conversion from accelerated approval to regular approval was based on data from an additional 123 patients and 25 months of added follow-up from the phase 1/2, open-label ARROW trial (ClinicalTrials.gov Identifier: NCT03037385).

The trial included patients with metastatic RET fusion-positive NSCLC whose disease had progressed on platinum-based chemotherapy as well as treatment-naïve patients with metastatic NSCLC. The patients received pralsetinib at 400 mg orally once daily until disease progression or unacceptable toxicity. The primary outcome measures were overall response rate (ORR) and duration of response (DOR).

Among the 130 patients previously treated with platinum chemotherapy, the ORR was 63%, the complete response rate was 6%, and the partial response rate was 57%. The median DOR was 38.8 months, and 66% of patients had responses lasting at least 12 months. In this study population, 54 patients had received an anti-PD-1/PD-L1 therapy either sequentially or concurrently with platinum-based chemotherapy. The ORR for this subgroup was 59%, and the median DOR was 22.3 months.

Among the 107 treatment-naïve patients, the ORR was 78%, the complete response rate was 7%, and the partial response rate was 71%. The median DOR was 13.4 months, and 45% of patients had responses lasting at least 12 months.

The most common adverse reactions reported were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough.

Gavreto is supplied as 100 mg capsules. Patients should be selected for treatment based on the presence of a RET gene fusion.

Gavreto is also approved for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). In July, Genentech announced that the approval of Gavreto for RET-mutant medullary thyroid cancer had been withdrawn.

References

US Food and Drug Administration. FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions. Accessed August 9, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pralsetinib-non-small-cell-lung-cancer-ret-gene-fusions.

Package insert. Genentech; 2023. Accessed August 9, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s009lbl.pdf.

This article originally appeared on MPR