FDA approves new drug to treat mutated breast cancer

By MDLinx staff
Published February 9, 2023

Key Takeaways

  • The FDA has approved a new drug to treat ESR1 mutated breast cancer.

  • The drug is available to postmenopausal women and men with certain types of breast cancer.

  • The drug may help to reduce mortality rates.

The Federal Drug Administration (FDA) has announced approval of a new drug to treat ESR1 mutated breast cancer, which is commonly hard to combat. []

The new drug, Orserdu (elacestrant), has been cleared to treat women who have gone through menopause and men with HER2-negative, ER-positive, ESR1-mutated advanced, or metastatic breast cancer. The metastatic breast cancer must also advance after one line of endocrine therapy.[][]

The drug is being manufactured through Stemline Therapeutics. Stemline Therapeutics is part of the Menarini Group out of Italy.

“There are treatments available to treat this type of cancer but a good portion of patients develop resistance to the treatments,” says Rajkumar Lakshmanaswamy, Ph.D., Chair of the Department of Molecular and Translational Medicine, Center of Emphasis in Cancer and Dean of L. Frederick Francis Graduate School of Biomedical Sciences at Texas Tech University Health Sciences Center El Paso. 

According to the American Cancer Society, breast cancer accounts for 30 percent of all cancer diagnoses in women. About 44,000 women will die from breast cancer in the United States this year.[] 

“The current drug approved by FDA is expected to be effective against this particular type of breast cancer where ESR1 is mutated and could reduce chemo resistance and recurrence of breast cancer. It could also reduce breast cancer related mortality,” says Lakshmanaswamy. 

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