FDA Grants Accelerated Approval to Lilly's Retevmo (Selpercatinib), the First Tumor-Agnostic RET Inhibitor for RET Fusion-Positive Solid Tumors

On September 22, Eli Lilly and Company announced that the U.S. FDA has granted accelerated approval for the expanded indication of Retevmo (selpercatinib) to treat patients with locally advanced or metastatic solid tumors that are positive for RET gene fusions. These patients have progressed during or after prior systemic therapy or have no satisfactory alternative treatment options. Reportedly, this is the world's first and only RET inhibitor approved for the treatment of RET fusion-positive solid tumors regardless of cancer type.

Moreover, the U.S. FDA has granted full approval to Retevmo for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) driven by RET gene fusions. The FDA broadened the indication for Retevmo to include patients with locally advanced disease and converted the accelerated approval for NSCLC granted in May 2020 to a full approval.

Selpercatinib is a highly potent and selective RET inhibitor that can block RET activity, help halt cancer cell growth, and has shown compelling preliminary evidence in patients with brain metastases. It was approved by the U.S. FDA on May 8, 2020, for the treatment of non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and thyroid cancer with RET gene fusions or mutations.

These two approvals were supported by data from the multicenter, open-label, multi-cohort pivotal clinical trial LIBRETTO-001. In the tumor-agnostic patient cohort (n=41), Retevmo achieved an overall response rate of 44%, with a median duration of response of 24.5 months, and 67% of patients had a response lasting more than 6 months. Efficacy results across different cancer types can be found in the figure below:

Image Source: References

Common adverse reactions include: cerebral edema (49%), diarrhea (47%), fatigue (46%), dry mouth (43%), hypertension (41%), abdominal pain (34%), constipation (33%), rash (33%), nausea (31%), headache (28%), cough (24%), vomiting (22%), dyspnea (22%), hemorrhage (22%), arthralgia (21%), QT interval prolongation (21%).

Reference Source:

https://www.prnewswire.com/news-releases/fda-approves-lillys-retevmo-selpercatinib-the-first-and-only-ret-inhibitor-for-adults-with-advanced-or-metastatic-solid-tumors-with-a-ret-gene-fusion-regardless-of-type-301630358.html

Editorial Responsibility: Liu Li

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