Eli Lilly's RET Inhibitor Retevmo Receives Full FDA Approval for RET Fusion-Positive Thyroid Cancer with 85% Response Rate in Pretreated Patients

Jun 13, 2024 07:57 CST Updated 07:58

Eli Lilly

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▎WuXiEdited by Kant Content Team

Today, the U.S. FDA announced,Convert the accelerated approval of Eli Lilly and Company's RET inhibitor Retevmo (selpercatinib) to full approval for the treatment of advanced or metastaticRETAdult and pediatric patients with fusion-positive thyroid cancer aged 2 years and older.These patients require systemic therapy and have developed resistance to radioactive iodine treatment.

The efficacy of Retevmo was evaluated in the clinical trial LIBRETTO-001, a multi-center, open-label, multi-cohort clinical trial involving 65 participants.RETPatients with fusion-positive thyroid cancer. The primary efficacy outcome measures were overall response rate (ORR) and duration of response (DOR).Among 41 previously treated patients, the ORR was 85% (95% CI: 71%, 94%), and among 24 patients who had not received systemic treatment, the ORR was 96% (95% CI: 79%, 100%). In the treated patients, the median DOR was 26.7 months, while in the untreated patients, the median DOR has not yet been reached.

Other supporting evidence includes 10 patients in the LIBRETTO-121 study.RETORR and DOR Data in Pediatric and Young Adult Patients with Fusion-Positive Thyroid Cancer: An International, Single-Arm, Multi-Cohort Clinical Trial for Children and Adolescents with Advanced RET-Altered Solid Tumors. In these patients,ORR was 60% (95% CI: 26%, 88%), with 83% of patients experiencing a duration of response lasting more than 12 months.

The most common adverse reactions (≥25%) are edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. The most common Grade 3 or 4 laboratory abnormalities (≥5%) are lymphopenia, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), decreased sodium, and decreased calcium.

Retevmo is a potent RET kinase inhibitor. It received accelerated approval from the U.S. FDA in 2020 for the treatment of three types of cancer: non-small cell lung cancer (NSCLC), medullary thyroid carcinoma (MTC), and thyroid cancer.These patients' tumorsRETGene fusion or mutation occurs.

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References:

[1] FDA approves selpercatinib for RET fusion-positive thyroid cancer. Retrieved June 12, 2024, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-ret-fusion-positive-thyroid-cancer

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