Health Canada Approves Elinzanetant (Lynkuet) to Treat Hot Flashes in Breast Cancer Patients

Health Canada has authorized elinzanetant查看药品详情, sold under the brand name Lynkuet (搜索)搜索该药品, to treat moderate to severe hot flashes and night sweats in breast cancer (搜索)搜索该疾病 patients. According to Health Canada's drug database, the new market authorization took effect on Friday. The drug, manufactured by Bayer (搜索)搜索该公司, was first approved in July 2025 to treat these symptoms in women going through menopause, but a subsequent study reviewed by the department demonstrated effectiveness specifically in breast cancer patients.

About two-thirds of breast cancers are hormone-receptor positive, meaning they require estrogen to grow. Oncologists treat these cancers by blocking the body's production of estrogen, which often triggers vasomotor symptoms such as hot flashes and night sweats. Elinzanetant查看药品详情 is a non-hormonal medication that reduces these symptoms by directly targeting neurons that can become hyperactive with a lack of estrogen.

An Unmet Need in Breast Cancer Care

Dr. Christine Brezden-Masley, medical director of the cancer program at Sinai Health in Toronto, said women with breast cancer (搜索)搜索该疾病 have had limited options to manage hot flashes and night sweats because they cannot take hormone replacement therapy like other women in menopause might. "The clinical trial with elinzanetant查看药品详情 was the very first one that actually looked at breast cancer patients on anti-estrogen therapy," said Brezden-Masley, who receives compensation as a consultant to Bayer (搜索)搜索该公司.

Breast cancer (搜索)搜索该疾病 patients generally must remain on anti-estrogen pills — also called endocrine therapy — for about five to 10 years, she said. The most commonly used anti-estrogen medications are tamoxifen查看药品详情 and aromatase inhibitors (搜索)搜索该药品, according to the Canadian Cancer Society. Chemotherapy can also put patients into menopause by stopping the ovaries from working, Brezden-Masley added.

Hot flashes and night sweats interfere with women's ability to function during the day and interrupt their sleep at night. Moderate hot flashes are defined as the feeling of heat along with sweating, while severe hot flashes are so intense they cause women to stop what they are doing. The symptoms can be so debilitating that some patients stop taking their cancer medication to halt them — an outcome oncologists want to prevent. "We work closely with them to ensure that we deal with all of those symptoms to ensure that they adhere to their breast cancer (搜索)搜索该疾病 therapy so we don't have breast cancer recurring," Brezden-Masley said.

Historically, clinicians have prescribed certain drugs off-label — including the anticonvulsant gabapentin查看药品详情 and the antidepressant Effexor查看药品详情 — to try to provide relief. "We've been kind of pulling old drugs that would have, you know, a little bit of a benefit for our patients and decrease their hot flashes," she said.

Dr. Dave Cescon, a medical oncologist and clinician scientist at Princess Margaret Cancer Centre in Toronto, said menopausal symptoms are a major issue for many breast cancer (搜索)搜索该疾病 patients and "historically have not been well addressed." Health Canada's review and approval of elinzanetant查看药品详情 as an effective therapy for hot flashes and night sweats in women with breast cancer "will be very helpful," said Cescon, who does not have any financial ties with Bayer (搜索)搜索该公司.

The OASIS-4 Trial

The expansion of Health Canada's authorization for elinzanetant查看药品详情 to specifically include women with breast cancer (搜索)搜索该疾病 was supported by Bayer (搜索)搜索该公司's OASIS-4 study. Elinzanetant is a neurokinin receptor (搜索)搜索该靶点 antagonist; neurokinin receptor antagonists target KNDy neurons that can become hyperactive with a lack of estrogen and trigger hot flashes and night sweats.

The Phase 3 randomized, placebo-controlled clinical trial evaluated 395 women between 18 and 70 years old receiving endocrine therapy for breast cancer (搜索)搜索该疾病 over 52 weeks. To qualify, participants had to be experiencing at least 35 moderate to severe hot flashes or night sweats per week. The study results showed a significant decrease in daily hot flashes and night sweats, as well as fewer sleep disturbances, among women taking elinzanetant查看药品详情 compared to those taking a placebo.

The most common side effects of elinzanetant查看药品详情 were drowsiness during the day, fatigue, and diarrhea. At the end of the trial, 91.6% of participants chose to keep taking elinzanetant for another two years.

A Patient's Perspective

Laurie Legere, a 47-year-old hospital administrator living in Toronto, found a lump in her breast just before her 44th birthday. She began chemotherapy to shrink the tumour before having it surgically removed — and that is when her hot flashes started. The symptoms were "really disruptive," affecting both her sleep and her daily life as she continued working throughout her cancer treatment. "I would just, you know, start getting hot flashes in the middle of meetings or the middle of presentations," Legere said. "The sleep was really, I think, the most difficult part because you're really trying to, you're trying to heal, you're trying to rest and it's just kind of impossible."

Those symptoms have continued as Legere takes endocrine therapy to prevent the cancer from coming back. She was referred to a menopause clinic, but with hormone replacement therapy off the table, the medications she tried either did not work well or caused side effects she could not tolerate. Legere has been on gabapentin查看药品详情 for about a year, but cannot take a dose high enough to make a difference because it makes her groggy, so she is coming off it. She has already obtained a prescription for elinzanetant查看药品详情. "I'm, yeah, looking forward to hopefully having a much better experience."

A spokesperson for Bayer (搜索)搜索该公司 said elinzanetant查看药品详情 is not currently publicly funded in Canada and did not provide the price.