Is Selpercatinib approved by the FDA?

Yes, Selpercatinib, marketed under the brand name Retevmo, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Selpercatinib on May 8, 2020, under an accelerated approval process.

What is Selpercatinib?

Selpercatinib is an oral medication classified as a multikinase inhibitor. It is used to treat specific types of cancer that have spread to other parts of the body (metastatic). The approval is for:

Non-Small Cell Lung Cancer (NSCLC) in adults
Thyroid Cancer (including medullary thyroid cancer and RET fusion-positive thyroid cancer) in adults and children aged 12 years and older

How Does Selpercatinib Work?

Selpercatinib targets cancers that have a specific genetic mutation called an abnormal RET gene. This gene fusion drives cancer cell growth, and Selpercatinib inhibits the action of the RET kinase, which is critical for the growth of these cancer cells.

Dosage and Administration

Selpercatinib is available in oral capsule form in two strengths: 40 mg and 80 mg. The dosage depends on the patient’s weight and the type of cancer being treated:

For patients weighing less than 50 kg: 120 mg orally twice daily
For patients weighing 50 kg or more: 160 mg orally twice daily

It is important to take Selpercatinib exactly as prescribed by the healthcare provider. The medication is usually taken every 12 hours.

Side Effects

Common side effects of Selpercatinib include:

Abnormal blood tests
High blood pressure
Tiredness
Dry mouth
Diarrhea
Swelling
Rash
Constipation

Serious side effects may occur and require immediate medical attention. These include:

Easy bruising or bleeding
Coughing up blood or vomit that looks like coffee grounds
Any wound that will not heal
Fast or pounding heartbeats
Liver problems (e.g., jaundice)

Warnings and Precautions

Selpercatinib can harm an unborn baby. Both men and women should use effective birth control during treatment and for at least one week after the last dose.
Patients with untreated or uncontrolled high blood pressure should not use Selpercatinib.
It is essential to inform the healthcare provider of any existing liver disease or a family history of long QT syndrome.
Breastfeeding is not recommended during treatment and for at least one week after the last dose.

Conclusion

Selpercatinib (Retevmo) is a significant therapeutic option for patients with RET-positive cancers, including non-small cell lung cancer and certain thyroid cancers. Approved by the FDA on May 8, 2020, it offers a targeted approach to treating cancers driven by RET genetic mutations. Patients should follow their healthcare provider’s instructions closely and report any side effects promptly.

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