Giredestrant Approval Expected in Late 2026

People living with hormone receptor-positive, HER2-negative breast cancer may soon have a new option for treatment. Giredestrant is expected to be approved by the U.S. Food and Drug Administration (FDA) for early-stage hormone receptor-positive, HER2-negative breast cancer on Nov. 30 and metastatic or stage IV breast cancer on Dec. 18. Giredestrant is a hormonal therapy medicine (also called endocrine or anti-estrogen therapy).

The excitement over giredestrant has been building since researchers announced the positive results of two clinical trials: lidERA and evERA.

The lidERA trial found that people with early-stage disease who took giredestrant for five years after surgery were 30% less likely to have the cancer come back (called risk of recurrence) than people who took tamoxifen or an aromatase inhibitor.

For metastatic breast cancer, the evERA trial found that giredestrant combined with everolimus (brand name: Afinitor) nearly doubled progression-free survival for people with ESR1-mutated cancers that grew after treatment with a CDK4/6 inhibitor and hormonal therapy compared to standard hormonal therapy (10 months compared to 5.5 months). Progression-free survival is how long people live without the cancer growing.

In both studies, pre- and peri-menopausal women as well as men received a LHRH (luteinizing hormone-releasing hormone) antagonist. In women, these medicines stop the ovaries from making estrogen and progesterone. In men, they stop the testicles from making testosterone.

Giredestrant is a type of hormonal therapy medicine called a selective estrogen receptor degrader (SERD). SERDs block estrogen from attaching to cancer cells in the breast. By sitting in the estrogen receptors in and on hormone receptor-positive breast cancer cells, SERDs stop estrogen from signaling the cells to grow. SERDs also reduce the number of estrogen receptors and change the shape of the receptors so they don’t work as well.

Giredestrant is a pill taken by mouth.

Like most cancer medicines, giredestrant can cause side effects. The most common side effects seen in people with early-stage breast cancer were joint pain, hot flashes, and headache. The most common side effects in people with metastatic breast cancer were mouth sores, diarrhea, and anemia.

For some people, giredestrant may cause more serious side effects, including heart problems. Like other oral SERDs, giredestrant can cause bradycardia, which is a slower-than-normal heart rate. But it’s reassuring to know that in the lidERA study, most of the cases of bradycardia were mild, caused no symptoms, and didn’t require people to pause or stop treatment.