Can fezolinetant be used in people with cancer or who are BRCA+?

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Prescribing Information including BOXED WARNING

Currently, no information is available on the safety and efficacy of fezolinetant for the treatment of vasomotor symptoms (VMS) in individuals with cancer or undergoing cancer treatment, but clinical studies are ongoing

In the Phase 3 trials, SKYLIGHT 1, 2 and 4, previous or current history of a malignant tumor, except basal cell carcinoma, was an exclusion criterion,^1–3 and the Phase 3 DAYLIGHT trial excluded participants with a history of a malignant tumor within the last five years, except basal cell carcinoma.⁴

The Phase 3 HIGHLIGHT 1 trial (NCT06440967) is ongoing to investigate the safety and efficacy of fezolinetant 45 mg for the treatment of moderate to severe VMS in women with Stage 0 to 3 hormone receptor positive (either HER-2⁺ or HER-2^-) breast cancer who are receiving stable maintenance adjuvant endocrine therapy (tamoxifen 20 mg or daily aromatase inhibitors) with or without gonadotrophin releasing hormone (GnRH) agonists/antagonists for a minimum of four months and not receiving chemotherapy.⁴ The trial is also designed to confirm the absence of drug-drug interactions between fezolinetant and the adjuvant endocrine therapies.
The Phase 4 OPTION-VMS real-world study (NCT06049797) is ongoing to assess the change in VMS bother in women with a confirmed diagnosis of VMS who are initiating nonhormonal therapy, including fezolinetant. Participants with non-metastatic (Stage 0 to 3) breast cancer receiving a stable regimen of adjuvant endocrine therapy, including tamoxifen or aromatase inhibitors, with or without GnRH analogues for ≥ 3 months prior to screening can be included.⁴
A non-clinical study in rats bearing MRMT-1 (mammary rat metastasis tumor-1) rat breast cancer cells indicated that fezolinetant prevented tamoxifen-induced hot flash-like symptoms (tail-skin temperature) without affecting the anticancer effect of tamoxifen (tumor volume).⁴

Johnson KA, Martin N, Nappi RE, et al. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocr Metab. 2023;108(8):1981-1997. https://dx.doi.org/10.1210/clinem/dgad058.
Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023;401(10382):1091-1102. https://dx.doi.org/10.1016/s0140-6736(23)00085-5.
Neal-Perry G, Cano A, Lederman S, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023;141(4):737-747. https://dx.doi.org/10.1097/aog.0000000000005114.
Data on file.