FDA approves new breast cancer treatment
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The FDA has approved the combination of Inluriyo and Verzenio for the treatment of adults with specific types of advanced or metastatic breast cancer.
The FDA has approved a new breast cancer treatment for patients with advanced and metastatic cancers, such as stage 4. The Food and Drug Administration approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Inluriyo and Verzenio are manufactured by Eli Lilly and Company.
The FDA announced the metastatic cancer treatment option was approved for “adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer…” in a news release on Friday.
The pairing of Inluriyo and Verzenio, both oral treatments, was shown to stop cancer from spreading or worsening among those with metastatic cancer for a median of 11.1 months, as opposed to 5.5 months when using Inluriyo alone. FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with imlunestrant and abemaciclib.
“We have an urgent need for effective and safe treatment options for patients with disease progression on adjuvant or first-line therapy. Combining therapies that work on two distinct drivers of tumor growth… is an important strategy to help address treatment resistance,” Komal Jhaveri, MD, FACP, FASCO, principal investigator for the trials, said in a release.
According to the release, Inluriyo contains a warning for embryo-fetal toxicity, and Verzenio contains warnings for severe diarrhea, neutropenia, interstitial lung disease/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicity, and increased serum creatinine without affecting renal function.
Patients experienced mild to moderate side effects when using the drugs in combination, including diarrhea, nausea, fatigue and decreased white blood cell count, among others.
The FDA noted the recommended dosage of Inluriyo is “400 mg orally once daily (on an empty stomach at least two hours before food or one hour after food).”
The recommended amount of Verzenio in combination with Inluriyo is “150 mg orally twice daily (with or without food) until disease progression or unacceptable toxicity.”
