Retevmo is an oral, selective RET kinase inhibitor, indicated for locally advanced or metastatic solid tumours with a rearranged during transfection (RET) gene fusion, after prior systemic treatment
Eli Lilly and Company (Lilly) has received the US Food and Drug Administration (FDA) approval for Retevmo (selpercatinib) to treat a type of metastatic solid tumours in adult patients.
Retevmo is an oral, selective RET kinase inhibitor, indicated for locally advanced or metastatic solid tumours with a rearranged during transfection (RET) gene fusion, after prior systemic treatment.
The US agency granted accelerated approval and a continued approval is anticipated in this indication, contingent upon verification of clinical benefit in the confirmatory trial.
In addition, the FDA has granted regular approval for Retevmo to treat RET gene fusion-positive metastatic non-small cell lung cancer (NSCLC) in adults, as detected by an FDA-approved test.
In May 2020, the US agency granted Retevmo an accelerated approval for the treatment of NSCLC and medullary thyroid cancer (MTC).
The current approval expands its indication to include patients with locally advanced diseases and converts the accelerated approval to a traditional approval.
Retevmo labelling contains warnings for hepatotoxicity, interstitial lung disease (ILD), hypertension, haemorrhagic events, hypersensitivity, and tumour lysis syndrome, among others.
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 regulatory approvals are supported by data from the LIBRETTO-001, a multicentre, open-label, multi-cohort clinical trial that evaluated RET inhibitors to treat RET-driven cancers.
The study enrolled patients with locally advanced or metastatic RET-driven solid tumours, including NSCLC.
Overall response rate (ORR) and duration of response (DOR), as assessed by a blinded independent review committee (BIRC), include the major efficacy outcomes.
Central nervous system (CNS) ORR and CNS DOR are prespecified secondary endpoints.
In the study, the participants achieved 61% ORR, including a complete response (CR) rate of 7.3% and a partial response (PR) rate of 54%.
LIBRETTO-001 trial co-investigator Vivek Subbiah said: “In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumour types in patients with RET-driven cancers, including pancreatic, colon and other cancers in need of new treatment options.
“These data and FDA approval of the tumour-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumour types.”