Lilly’s RET Inhibitor Retsevmo Granted Conditional Marketing Authorization in the UK for Advanced RET Fusion-Positive Lung and Thyroid Cancers
Eli Lilly
Global Pharmaceutical R&D and Production Company
Medicines and Healthcare products Regulatory Agency
The MHRA is an executive agency of the UK Department of Health and Social Care, responsible for ensuring that medicines and medical devices work effectively and are safe and reliable. Established in 2003 through the merger of the Medicines Control Agency and the Medical Devices Agency, the organization employs more than 1,300 staff members.
Compiled by river
On March 11, according to foreign media reports, the UK Medicines and Healthcare products Regulatory Agency granted conditional marketing authorization for Eli Lilly and Company’s Retsevmo for the treatment of advanced RET fusion-positive lung cancer and thyroid cancer.
In particular, the approval includes Restevmo (selpercatinib) as the sole treatment option for patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy prior to receiving immunotherapy and/or platinum-based chemotherapy.
It also includes adults with advanced RET fusion-positive thyroid cancer who require systemic therapy after treatment with sorafenib or lenvatinib, as well as adults and adolescents aged 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC) who require systemic therapy after treatment.
The approval by the UK Medicines and Healthcare products Regulatory Agency was based on the results of the LIBRETTO-001 Phase I/II trial, a single-arm study involving more than 700 patients with RET-driven cancers.
The preliminary analysis included 105 patients who had previously received treatment for non-small cell lung cancer (NSCLC), with 64% of patients responding to treatment and a mean duration of response of 17.5 months. Among patients with previously treated RET-mutant medullary thyroid carcinoma (MTC), the preliminary analysis of 55 patients showed a response rate of 69.1%.
Yvonne Summers, Consultant Medical Oncologist at The Christie NHS Foundation Trust, said, “This is good news for patients with RET-driven cancers, as they will soon have a treatment option that directly targets RET alterations. Trial results showed a median duration of response of 17.5 months, representing a significant advance in this growing field of patient care.”
RET fusion-positive tumors occur in 1–2% of patients with non-small cell lung cancer (NSCLC) and are more commonly seen in individuals under the age of 60.
Reference source: MHRA authorises Lilly’s RET inhibitor Retsevmo
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.