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

Research C for DE and. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. FDA. Published online January 27, 2023.

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.

Fda greenlights first drug for esr1-mutated breast cancer.

Research C for DE and. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. FDA. Published online January 27, 2023.

The drug is being manufactured through Stemline Therapeutics. Steamline 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.

Breast cancer statistics | how common is breast cancer?

“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.