Retevmo Receives Full FDA Approval for Certain RET Fusion–Positive Cancers

Retevmo (selpercatinib) has received traditional, or full, FDA approval for adults and children age 2 years and older with certain advanced solid tumors that have a RET gene fusion. The approval expands on an earlier accelerated approval and reinforces the importance of comprehensive biomarker testing for people with advanced cancer.

On July 14, 2026, the FDA granted traditional approval to Retevmo for people with locally advanced or metastatic solid tumors that have a RET fusion identified by an FDA-approved test. To be eligible, a person’s cancer must have progressed during or after prior systemic treatment, or there must be no satisfactory alternative treatment option.

This tissue-agnostic approval means the treatment may be considered based on the tumor’s RET fusion—not only where in the body the cancer began.

What is Retevmo?

Retevmo is a targeted therapy taken by mouth. Its generic name is selpercatinib.

Some cancers have changes in a gene called RET. A RET fusion occurs when part of the RET gene becomes joined to another gene. This can create an abnormal signal that helps cancer cells grow and spread.

Selpercatinib is designed to block the activity of abnormal RET proteins. It has previously been used for certain RET fusion–positive non-small cell lung cancers and thyroid cancers. The new FDA decision confirms its use for a broader group of advanced RET fusion–positive solid tumors when the treatment criteria are met.

Which cancers may be included?

The FDA evaluated Retevmo in 75 people with RET fusion–positive cancers other than non-small cell lung cancer and thyroid cancer. Participants had locally advanced or metastatic cancer that had progressed after systemic therapy or had no satisfactory alternative treatment option.

Responses to Retevmo occurred in several cancer types, including:

• Colorectal cancer

• Pancreatic adenocarcinoma

• Bile duct cancer (cholangiocarcinoma)

• Salivary gland cancer

• Soft-tissue sarcoma

• Breast cancer

• Ovarian cancer

• Small-intestine cancer

• Bronchial carcinoid and other neuroendocrine tumors

• Skin carcinoma

• Cancer of unknown primary origin

Not every person with one of these cancers will have a RET fusion, and not everyone with a RET fusion will be a candidate for Retevmo. Testing and treatment decisions should be individualized with an oncology team.

What did the study find?

The FDA’s decision was supported by the LIBRETTO-001 clinical trial. Among the 75 people with RET fusion–positive solid tumors other than lung or thyroid cancer:

• 47% had their tumors shrink partially or completely.

• Among people whose tumors responded, the median duration of response was 24.5 months.

“Median” means the midpoint: half of responding patients had a response lasting longer than this time and half had a shorter response. Clinical-trial outcomes do not predict exactly how an individual person will respond.

The approval was also supported by results in RET fusion–positive non-small cell lung cancer and thyroid cancer, as well as pediatric and young-adult data from the LIBRETTO-121 trial. In that pediatric study, responses were seen in some patients with RET fusion–positive thyroid cancer, congenital infantile fibrosarcoma, and spindle-cell sarcoma.

What does “traditional approval” mean?

The FDA can initially grant accelerated approval for a drug based on early evidence suggesting it may provide meaningful benefit for a serious disease. The company must then complete additional studies to confirm the expected clinical benefit.

Retevmo first received accelerated approval for the tissue-agnostic RET fusion–positive solid-tumor indication in adults in 2022 and in children age 2 and older in 2024. The July 2026 decision converts that earlier accelerated approval to traditional approval.

For patients and families, traditional approval means that the FDA has completed its review of the additional evidence required for the broader RET fusion–positive solid-tumor use. It does not mean the treatment is right for every person with cancer; the tumor must meet the FDA-approved eligibility criteria.

Side effects and monitoring

Retevmo can cause serious side effects. Your care team will monitor you with blood tests, vital signs, and other evaluations as needed.

Important warnings and precautions in the prescribing information include:

• Liver problems

• Lung inflammation, also called interstitial lung disease or pneumonitis

• High blood pressure

• Changes in heart rhythm, including QT prolongation

• Bleeding events

• Allergic or hypersensitivity reactions

• Tumor lysis syndrome, a potentially serious reaction that can occur when cancer cells break down quickly

• Problems with wound healing

• Low thyroid hormone levels

• Harm to an unborn baby during pregnancy

In children, the prescribing information also warns about a hip-bone condition called slipped capital femoral epiphysis, also called slipped upper femoral epiphysis.

Contact your oncology team promptly about new or worsening symptoms, particularly shortness of breath, cough, fever, yellowing of the eyes or skin, unusual bleeding or bruising, severe fatigue, dizziness, fainting, chest symptoms, swelling, or a rapid or irregular heartbeat.

Why biomarker testing matters

RET fusions are not identified by symptoms, imaging scans, or tumor location alone. They require a biomarker test performed on tumor tissue and, in some cases, blood. The FDA approval specifies that the RET fusion should be detected by an FDA-approved test.

For people with advanced solid tumors, especially when standard treatment has stopped working or no satisfactory options remain, ask the cancer care team whether broad molecular testing—often called next-generation sequencing or NGS—has been performed.

Questions to ask your oncologist

• Has my tumor been tested for RET fusions?

• Was my test performed with an FDA-approved assay, and do I need additional testing?

• Does my cancer meet the FDA-approved criteria for Retevmo?

• What other treatment options or clinical trials should I consider?

• How would I take Retevmo, and how often would I need monitoring?

• Which side effects require an urgent call to the care team?

• Could Retevmo affect other medicines, supplements, or vitamins I take?

For adults and adolescents age 12 and older, the FDA-recommended dose is based on body weight: 120 mg twice daily for those weighing less than 50 kg and 160 mg twice daily for those weighing 50 kg or more. Dosing for children ages 2 to under 12 years is different and should be determined using the FDA prescribing information and the child’s care team.

Retevmo’s full approval provides another example of how precision medicine can guide treatment: a specific genetic change in a tumor may open treatment options across several cancer types.

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