Women taking tamoxifen or an aromatase inhibitor for breast cancer may soon have an FDA-approved, nonhormonal option for the hot flashes these pills often cause. The FDA has accepted Bayer's application to add endocrine therapy-related hot flashes to the label of Lynkuet (elinzanetant) and granted it priority review, according to a Bayer announcement about the FDA's priority review released Sept. 28. The drug is not approved for this use yet, and Bayer did not say when the agency is expected to decide.
For many patients, this is about more than comfort. Endocrine therapy is typically prescribed for five to 10 years to lower the chance that hormone receptor-positive breast cancer returns. Estrogen-based menopause treatment, the usual choice for severe hot flashes, is generally avoided after this type of cancer, which leaves patients relying on off-label medicines or simply enduring the symptoms.
