The U.S. Food and Drug Administration (FDA) has given a Priority Review designation to Bayer’s Lynkuet to expand its use in treating vasomotor symptoms (VMS) in women with menopause to include women receiving endocrine therapy for breast cancer.

Lynkuet, approved a year ago for treatment of moderate to severe VMS in menopause, has been accepted as a supplemental New Drug Application (sNDA) for cancer patients based on results from a Phase III OASIS-4 investigational study, Bayer said.

“Currently, there are no FDA approved treatment options for moderate to severe vasomotor symptoms associated with endocrine therapy in patients with HR+ breast cancer in the U.S.,” said Kristie Baisden DO, Vice President, U.S. Medical Affairs, Women’s Health at Bayer. “This treatment gap underscores an important unmet medical need for this population.”

Breast cancers account for 30 percent of all cancers in women and 70 percent of those are HR+, for which endocrine therapy is recommended. Treatment is a minimum of five years and as long as 10 and hot flashes are a common side effect.

“Endocrine therapy is a standard of care for many women facing HR+ breast cancer and can commonly cause side effects such as vasomotor symptoms,” said OASIS-4 Primary Investigator Fatima Cardoso, MD, Head of Clinical Trials, Scientific Affairs and International Development in Breast Oncology, Centre Antoine Lacassagne and Advanced Breast Cancer (ABC) Global Alliance, Nice, France. “It’s important that we continue to learn more about vasomotor symptoms due to endocrine therapy as part of supporting women throughout their breast cancer care journey.”