Retevmo (selpercatinib, 40 mg & 80 mg capsules) is indicated to treat locally advanced or metastatic solid tumours in adult patients with a rearranged during transfection (RET) gene fusion, which have progressed on or after previous systemic treatment.
The regulator has approved this indication under accelerated approval and a continued approval is expected for this indication, contingent upon verification of clinical benefit in the confirmatory trial.
Additionally, the US FDA has granted traditional approval for Retevmo to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with a RET gene fusion, as detected by an FDA-approved test.
In May 2020, the regulator approved Retevmo under accelerated approval regulations to treat NSCLC in adult patients and advanced or metastatic RET-mutant medullary thyroid cancer (MTC) in paediatric patients aged 12 years and above.
The latest approval expands Retevmo’s indication to include patients with locally advanced diseases and converts the accelerated approval given in May 2020 to a traditional approval.
Loxo@Lilly chief medical officer David Hyman said: “Since its initial accelerated approval, Retevmo has shifted the treatment paradigm for patients with RET-altered cancers.
“Retevmo is the first and only RET inhibitor to receive both tumour-agnostic accelerated approval and traditional approval in NSCLC, further supporting its ability to deliver meaningful clinical benefit for patients across diverse tumour types.”
The two US FDA approvals are supported by data obtained from the multi-cohort, open-label, multicentre LIBRETTO-001 clinical trial.
In the study, patients with locally advanced or metastatic RET-driven solid tumours, including NSCLC, were enrolled.
Overall response rate (ORR) and duration of response (DOR), which were evaluated by a blinded independent review committee (BIRC), are the major efficacy outcomes of the study.
Central nervous system (CNS) ORR and CNS DOR are the study’s prespecified secondary endpoints.
The company noted that the Retevmo labelling includes warnings and precautions for interstitial lung disease (ILD)/pneumonitis, QT interval prolongation, hepatotoxicity, tumour lysis syndrome, hypersensitivity, hypertension, hypothyroidism, hemorrhagic events, embryo-fetal toxicity, and impaired wound healing risk.