Eli Lilly first studied the effectiveness of using a RET inhibitor as a treatment for early-stage non-small cell lung cancer. The company's drug, Retevmo, significantly increased the survival rate of participants in the final studies.

The drug Retevmo (selpercatinib) from Eli Lilly statistically significantly increased survival in participants in the LIBRETTO-432 Phase III clinical trial (CT) with early-stage non-small cell lung cancer (NSCLC). The American manufacturer announced this in a press release.

Retecmo is a highly selective low-molecular-weight RET tyrosine kinase inhibitor. This gene encodes a receptor on the surface of cells that triggers their division. Mutations cause its excessive activation, and cells begin to multiply uncontrollably, leading to the formation of a malignant tumor. Selpercatinib blocks oncogenic signals from the receptor.

The US Food and Drug Administration (FDA) approved it under an accelerated procedure (allows sales to begin but requires additional clinical trials) in 2020. Three indications were approved at once: metastatic NSCLC, advanced or metastatic thyroid cancer, and medullary thyroid cancer. Four years later, a full registration certificate was issued. Today, it is approved for use in treating all RET-associated solid tumors in cancer patients over two years of age who have not responded to other treatments.

The RET inhibitor is being studied for the first time as an adjuvant treatment for early-stage NSCLC in Phase III clinical trials, the final stage before submission to regulatory authorities. It included 151 people with stages IB-IIIA — the tumor has not yet spread beyond the lung and chest cavity, remains relatively small (up to 4 cm in IB, becoming larger in subsequent stages of progression with involvement of nearby lymph nodes) and can be removed. They had previously undergone surgery or a course of radiation therapy. Some also received adjuvant chemotherapy. They were given selpercatinib (120 or 160 mg depending on weight, twice daily) or a placebo.

The data showed that selpercatinib statistically significantly reduced the risk of recurrence or death. The exact figures are not disclosed. There are also no definitive conclusions on overall survival, but the drug is believed to be more effective than placebo. The safety profile was consistent with previously known information.

Sales of Retevmo amounted to $364 million in 2024 and $456 million in 2025. Eli Lilly acquired the drug as a result of its $8 billion acquisition of biotech startup Loxo Oncology in 2019, one of the largest deals in the oncology segment in the past decade.

Its only direct competitor remains Gavreto (pralsetinib) from Blueprint Medicines, which also entered the US market in 2020, but four months later. In 2024, Rigel Pharmaceuticals acquired the rights to the drug.

Lung cancer claims the most lives: according to Globocan estimates, it accounts for one in five cancer deaths worldwide. In 2022, 2.5 million people were diagnosed with lung cancer, of whom 1.8 million (72%) died. In most cases (85%), the non-small cell form is detected. With NSCLC, the chances of living longer than five years are about 28%. In the early stages, this figure reaches 64%, but in the presence of metastases, it drops to 9%.

 

Source: Eli Lilly and Company