MHRA authorises Lilly’s RET inhibitor Retsevmo

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Eli Lilly’s Retsevmo a conditional marketing authorisation for the treatment of RET fusion-positive advanced lung cancer and thyroid cancer.

In particular, the authorisation includes Restevmo (selpercatinib) as monotherapy treatment for adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

It also includes the treatment of adults with advanced RET fusion-positive thyroid cancer who require systemic therapy after prior treatment with sorafenib/lenvatinib, and also for adults and adolescents aged 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment.

The MHRA authorisation is based on results from the LIBRETTO-00 Phase I/II trial, a single-arm study of over 700 patients with RET-driven cancers.

The primary analysis included 105 previously treated patients with NSCLC – 64% of these participants responded to treatment with an average duration of response of 17.5 months.

In previously treated RET-mutant MTC patients, the primary analysis of 55 patients had a 69.1% response rate.

“This is good news for patients living with RET-driven cancers as they will soon have a treatment option that targets RET alterations directly,” said Yvonne Summers, consultant oncologist at The Christie NHS Foundation Trust.

"With trial results showing median benefit of 17.5 months, this treatment represents a significant advancement in this growing field,” she added.

RET fusion-positive tumours occur in 1-2% of NSCLC patients, and are more commonly found in people who are below the age of 60 years.