FDA Approvals Roundup: Pluvicto, Cabenuva, Fintepla
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New approval
Pluvicto approved for metastatic, castration-resistant prostate cancer
Advanced Accelerator Applications’ Pluvicto (lutetium [Lu 177] vipivotide tetraxetan; injection) is approved as a radioligand therapy for metastatic castration-resistant prostate cancer in men who are positive for prostate-specific membrane antigen and have been treated with an androgen receptor pathway inhibitor and taxane-based chemotherapy.
Locametz (gallium Ga 68 gozetotide), a radioactive diagnostic agent, was concurrently approved for selecting patients for treating with Pluvicto.
Approval of Pluvicto was based on findings from the multicenter, open label VISION trial in which patients from the indicated population were randomized 2:1 to receive Pluvicto plus best standard of care (BSoC; 551 patients) or BSoC alone (280 patients). Median overall survival in the Pluvicto group was 15.3 months, compared with 11.3 months BSoC arm. Interpretation of the magnitude of the radiographic progression-free survival effect was limited due to a high degree of censoring from early dropout in the control arm.
The review of this application used the assessment aid. The application was granted priority review and breakthrough designations.
New indications
Cabenuva HIV regimen nabs expanded indication for adolescents
ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine) has been granted a new indication for treating HIV-1 in virologically suppressed patients aged 12 years or older.
The long-acting regimen was codeveloped with Janssen as a once-monthly or every-two-months’ treatment. It contains ViiV's cabotegravir and Janssen’s rilpivirine, both extended release injectable suspensions.
Approval for the expanded indication was supported by efficacy findings extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure and from safety data from the week 16 interim analysis of the ongoing MOCHA study in 23 patients from the indicated population.
Cabenuva was originally approved in 2021 for treating adults living with HIV-1.
Fintepla okayed for seizures associated with Lennox-Gastaut syndrome
UCB’s Fintepla (fenfluramine; oral solution) has been granted a new indication for treating seizures associated with Lennox-Gastaut syndrome in patients aged 2 years or older.
Fintepla was originally approved in 2020 for the treatment of seizures associated with Dravet syndrome in the same age group. The therapy was developed by Zogenix, which was acquired by UCB in March 2022.
Approval of Fintepla was based on findings from a Phase 3 global, placebo-controlled clinical trial in 263 patients from the indicated population. Monthly seizure frequency dropped by a median 23.7% from baseline in patients receiving Fintepla, compared with 8.7% in those receiving placebo.
Fintepla comes with a warning for valvular heart disease and pulmonary arterial hypertension.
