New era of genomic medicine begins as UK approves Lilly's Retsevmo

The UK regulator has authorised Eli Lilly’s targeted cancer drug Retsevmo for tumours with RET fusion positive lung cancers and thyroid cancers, which the company said could herald a new era of genomic medicine for the NHS.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval for Retsevmo (selpercatinib) as monotherapy for adults with advance RET fusion-positive non-small cell lung cancer requiring systemic therapy after previous immunotherapy and/or chemotherapy treatment.

The label also covers adults with advanced RET fusion-positive thyroid cancer who require systemic therapy after previous treatment with sorafenib/lenvatinib.

Retsevmo can also be used in adults and adolescents aged 12 years and older with advanced RET-mutant medullary thyroid cancer, requiring systemic therapy following previous treatment with cabozantinib and/or vandetanib.

Approved shortly after a similar decision in Europe, the drug is an oral therapy, designed to help prevent cancer cells from growing by targeting the specific driver of certain RET-mutated advanced or metastatic cancers.

Lilly said that this will just be the beginning of this kind of approach to cancer in the UK, where the mutation present informs the choice of therapy rather than the tumour’s location in the body.

Merck & Co’s Keytruda (pembrolizumab) can also be used like this to target cancers with MSI-high or mismatch repair deficient mutations and last year Roche began a potential $1.7 billion collaboration with Blueprint Medicines to develop a rival RET inhibitor, pralsetinib.

An Eli Lilly spokesperson said: “It is clear that the UK government’s goal is for the UK to create the most advanced genomics healthcare ecosystem in the world.

“The new NHS Genomics Medicine Service (GMS) aims to embed genomic medicine into the NHS which will be crucial to help identify which patients are potential candidates for targeted therapies.

“The roll out of genomic testing (Whole Genome Sequencing -WMS) as a routine part of cancer diagnosis, together with the introduction of new targeted therapies, has the potential to significantly improve patient outcomes and quality of life.”

Retevmo was approved in the US in May last year and is the second approved drug to spring from Lilly’s takeover of Loxo Oncology in 2019.

The conditional authorisation was based on data from the LIBRETTO-001 phase 1/2 trial, in which 64% of previously treated patients with non-small cell lung cancer (NSCLC) responded to treatment with an average duration of response of 17.5 months. In the previously treated RET-mutant medullary thyroid cancer patients, a 69.1% response rate was observed.