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Lilly’s cancer drug Retsevmo gets UK approval for multiple indications

pharmafile | March 10, 2021 | News story | Research and Development Cancer, Eli Lilly, MHRA 

The MHRA has granted conditional marketing authorisation for Eli Lilly’s Retsevmo (selpercatinib) as monotherapy for a number of cancer indications.

The agency approved selpercatinib for the treatment of 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; the treatment of adults with advanced RET fusion positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib; and the treatment of adults and adolescents 12 years and older with advanced RET mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with cabozantinib and/or vandetanib.

The drug was granted authorisation based on the LIBRETTO-001 Phase I/II trial’s endpoints of objective response rate and duration of response.

Selpercatinib was evaluated in the single-arm, multi-centre Phase I/II LIBRETTO-001 trial of over 700 of patients with RET-driven cancers. In the primary analysis of 105 previously treated patients with NSCLC, 64% responded to treatment with an average duration of response of 17.5 months.  In the previously treated RET-mutant MTC patients, primary analysis of 55 patients had a 69.1% response rate.

Lung cancer is the third most common cancer, with 85,000 people in the UK having received a lung cancer diagnosis. Among these patients, NSCLC contributes to between 80% and 90% of all cases. RET fusion-positive tumours occur in 1% to 2% of NSCLCs, and are more commonly found in people who are aged under 60.

There are around 3,700 new thyroid cancer cases in the UK every year, with cases being three times more common in women than in men. MTC is rare form of thyroid cancer, accounting for approximately 3% of adult thyroid cancers, yet has poorer long-term outcomes compared to other types.

Dr Jyun-Yan Yang, Senior Medical Director for Lilly in Northern Europe, said:  “Lilly is committed to delivering life-changing medicines to people living with cancer, and we are delighted that the MHRA has granted conditional authorisation of selpercatinib for people with advanced or metastatic RET-driven lung and thyroid cancers.

“The development of targeted therapies can offer patients new treatment options with improved outcomes, potentially giving them more time with their loved ones.”

Darcy Jimenez

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