FDA News

FDA approves Verzenio for hormone receptor-positive, HER-2-negative breast cancer

The FDA approved abemaciclib for the treatment of women with hormone receptor-positive HER-2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.

The agency approved abemaciclib (Verzenio, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor —in combination with fulvestrant (Faslodex, AstraZeneca) following progression on endocrine therapy, and as a monotherapy for patients with metastatic disease previously treated with endocrine therapy and chemotherapy.

“Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment and unlike, other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA-issued release.

The approval of the abemaciclib combination included data from a randomized trial designed to evaluate the efficacy and safety of abemaciclib compared with placebo — both in combination with fulvestrant — in 669 patients with hormone receptor-positive, HER-2-negative breast cancer who progressed after treatment with endocrine therapy and who had not received chemotherapy once the cancer had metastasized.

Patients treated with the abemaciclib combination achieved superior PFS compared with patients assigned placebo (16.4 months vs. 9.3 months).

The monotherapy approval included data from a single-arm trial that evaluated the efficacy and safety of abemaciclib in 132 patients with hormone receptor-positive, HER-2-negative breast cancer who progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasized.

Overall, 19.7% of patients experienced complete or partial shrinkage of their tumors for a median of 8.6 months.

Common side effects include diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting and headache.

Serious adverse events included diarrhea, neutropenia, elevated liver blood tests and blood clots.

The FDA had granted this application priority review and breakthrough therapy designations.

The FDA approved abemaciclib for the treatment of women with hormone receptor-positive HER-2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.

The agency approved abemaciclib (Verzenio, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor —in combination with fulvestrant (Faslodex, AstraZeneca) following progression on endocrine therapy, and as a monotherapy for patients with metastatic disease previously treated with endocrine therapy and chemotherapy.

“Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment and unlike, other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA-issued release.

The approval of the abemaciclib combination included data from a randomized trial designed to evaluate the efficacy and safety of abemaciclib compared with placebo — both in combination with fulvestrant — in 669 patients with hormone receptor-positive, HER-2-negative breast cancer who progressed after treatment with endocrine therapy and who had not received chemotherapy once the cancer had metastasized.

Patients treated with the abemaciclib combination achieved superior PFS compared with patients assigned placebo (16.4 months vs. 9.3 months).

The monotherapy approval included data from a single-arm trial that evaluated the efficacy and safety of abemaciclib in 132 patients with hormone receptor-positive, HER-2-negative breast cancer who progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasized.

Overall, 19.7% of patients experienced complete or partial shrinkage of their tumors for a median of 8.6 months.

Common side effects include diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting and headache.

Serious adverse events included diarrhea, neutropenia, elevated liver blood tests and blood clots.

The FDA had granted this application priority review and breakthrough therapy designations.