Eli Lilly’s Retevmo approved by FDA to treat lung and thyroid cancers

pharmafile | May 11, 2020 | News story | Sales and Marketing COVID-19, coronavirus 

The FDA has announced that Retevmo (selpercatinib) has been approved to treat both non-small-cell lung cancer (NSCLC) and medullary thyroid cancer.

This includes other types of thyroid cancers in patients whose tumours have an alteration in rearranged during transfection (RET) gene.

Retevmo had previously received priority review in January under its accelerated approvals regulations. This was based on the LIBRETTO-001 Phase I/II trials that treated 702 patients with a variety of advanced solid tumours, including NSCLC and thyroid cancers.

In this trial, Retevmo’s efficacy in 105 patients with RET fusion positive NSCLC (who were previously treated with platinum chemotherapy) had an objective response rate of 64%.

Also in this trial, 143 patients with RET-mutant MTC were tested for efficacy, with 55 who had previously been treated with cabozantinib, vandetanib or both, with the other 88 having not being treated by any approved therapy. The objective response rate was 64%.

Eli Lilly said that there was a 5% discontinuation rate due to adverse reactions with the most common being pneumonia.

Dr Alexander Drilon, lead investigator for LIBRETTO-001, commented on the trial and said: “we observed that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib, including responses in difficult-to-treat brain metastases.

“The approval of selpercatinib marks an important milestone in the treatment of NSCLC, making RET-driven cancers now specifically targetable in the same manner as cancers with activating EGFR and ALK alterations, across all lines of therapy. I am pleased that patients with these RET-driven cancers have this newly approved option.”

Conor Kavanagh

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