Zhitong Financial APP learned that$Eli Lilly and Co (LLY.US)$It has been announced that FDA has officially approved its oral lung cancer drug Retevmo to be put on the market.

This decision is based on key data from the LIBRETTO-001 trial, which reflects the effect of Retevmo on the total response rate (ORR) and response duration (DOR) of multiple tumor types.

The treatment, also known as selpercatinib, is used to treat locally advanced or metastatic solid tumors, accompanied by recombinant (RET) gene fusion during transfection, and is suitable for patients whose cancer is progressing or there is no satisfactory alternative treatment despite previous systemic treatment.

At the same time, the accelerated approval granted by FDA to Retevmo in May 2020 converted to traditional approval for certain patients with non-small cell lung cancer (NSCLC). According to the routine approval of FDA, the treatment is suitable for locally advanced or metastatic NSCLC adult patients with RET gene fusion detected by FDA authorized tests.

Hepatotoxicity, interstitial lung disease, and hemorrhagic events are warnings cited in Retevmo tag messages.

Although the LIBRETTO-001 test showed that the ORR of Retevmo was 44%, the research data as of September 2020 showed an objective effective rate of 47%, which means that the size of the tumor is decreasing.