Is Elacestrant approved by the FDA?

Yes, Elacestrant, marketed under the brand name Orserdu, is FDA approved. It was approved by the FDA on January 27, 2023, for the treatment of advanced or metastatic breast cancer in postmenopausal women and adult men.

Indications 

Elacestrant is specifically used to treat advanced hormone-related breast cancer in patients where the cancer has progressed or metastasized after other treatments have failed. It targets estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated breast cancer.

Usage and Dosage

The usual adult dose for treating breast cancer is 345 mg taken orally once a day with food. Treatment continues until there is disease progression or unacceptable toxicity. It is crucial to follow the doctor's instructions and not alter the dosage without medical advice.

Common Side Effects

• Muscle and joint pain
• Nausea, vomiting, loss of appetite
• Increased cholesterol and triglyceride levels
• Abnormal kidney or liver function tests
• Headache
• Diarrhea, constipation
• Fatigue
• Stomach pain, heartburn
• Low blood sodium
• Hot flushes
• Anemia (low red blood cells)

Serious Side Effects

• Allergic reactions (hives, difficulty breathing, swelling of the face, lips, tongue, or throat)
• Signs of genital infection (burning, itching, odor, discharge, pain, tenderness, redness, or swelling)
• Nausea, vomiting, stomach pain, or tiredness
• Signs of bladder infection (pain or burning during urination, increased urination, blood in urine, fever, pain in pelvis or back)
• Low blood sugar symptoms (headache, weakness, drowsiness, confusion, hunger, sweating, irritability, dizziness, fast heart rate, feeling anxious or shaky)
• Redness, swelling, pain, or tenderness in the genital or anal area

Warnings and Precautions

• Elacestrant can harm an unborn baby. Both men and women should use birth control during treatment and for at least 1 week after the last dose.
• It is essential to inform the doctor of any history of high cholesterol, triglycerides, or liver disease.
• Do not breastfeed while using elacestrant and for at least 1 week after the last dose.
• Elacestrant may affect fertility in both men and women.

Conclusion

Elacestrant, branded as Orserdu, is an FDA-approved medication for treating specific types of advanced or metastatic breast cancer. It offers a treatment option for patients with hormone-related breast cancer that has progressed despite other treatments. As with all medications, it is important to adhere to medical advice and be aware of potential side effects and precautions.

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