No limit to cancer! Eli Lilly RET inhibitor Retevmo approved by the US FDA for the treatment of RET gene fusion positive solid tumors!

Eli Lilly recently announced that the U.

Retevmo is a potent oral, highly selective, replay during transfection (RET) kinase inhibitor that blocks RET kinase and prevents cancer cell growth
.

It is worth mentioning that Retevmo is the first and only RET inhibitor approved for use in adults with RET-positive advanced or metastatic solid tumors of RET gene fusion, regardless of their tumor type
.

In addition to the "unlimited cancer" indications described above, the FDA has also translated an accelerated approval from Retevmo to routine approval for the treatment of adults with
locally advanced or metastatic non-small cell lung cancer (NSCLC) that has been confirmed positive for RET gene fusion by an FDA-approved test product.

Vivek Subbiah, co-investigator of the LIBRETTO-001 trial, associate professor of therapeutics for cancer research at the University of Texas MD Anderson Cancer Center, said: "The LIBRETTO-001 trial results show that selpercatinib has shown clinically significant and long-lasting efficacy
in patients with RET-driven cancers, including pancreatic cancer, colon cancer and other cancers that require new treatment regimens 。 These data, along with FDA approvals for unlimited cancer indications, underscore the importance of routine, comprehensive genomic testing of
patients with multiple tumor types.

Dr David Hyman, Chief Medical Officer of Eli Lilly Oncology, said: "Since initial accelerated approval, Retevmo has changed the treatment model
for cancer patients carrying changes in the RET gene.

It is estimated that RET fusion is present in approximately 2% of non-small cell lung cancers (NSCLC), 10-20% of papillary thyroid cancers (PTCs) and other types of thyroid cancers, as well as other cancers (e.

Retevmo is a potent oral, highly selective, rework during transfection (RET) kinase inhibitor used to treat cancer patients with
RET abnormalities.

The above "unlimited cancer" accelerated approval and NSCLC routine approval, based on critical Phase 1/2 LIBRETTO-001 trial data
.

RET fusion-positive solid tumors: Among the 41 patients in the "unlimited cancer" dataset, the most common cancers were pancreatic cancer (27%), colorectal cancer (24%), salivary adenocarcinoma (10%), and unknown primary cancer (7%)
.

Overall efficacy data (Image source: Eli Lilly)

The efficacy of patients who have received platinum-based chemotherapy and treatment-naive RET fusion-positive NSCLC is summarized as follows:

NSCLC efficacy data (Image source: Lilly)

Efficacy results of CNS metastatic RET fusion-positive NSCLC patients: (1) Among patients with CNS metastatic RET fusion-positive NSCLC who have previously received treatment, the intracranial lesion ORR was 87.

In the LIBRETTO-001 safety assessment population (n=796), the most common adverse effects (≥25%) in patients with advanced solid tumors were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache
.

FDA Approves Lilly's Retevmo® (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type