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FDA expands Verzenio approval for breast cancer
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The FDA expanded the approval of abemaciclib to include its use in combination with an aromatase inhibitor as initial endocrine-based therapy for certain women with advanced or metastatic breast cancer, according to the agent’s manufacturer.
The approval applies to postmenopausal women with hormone receptor-positive, HER-2-negative disease.
This is the third FDA approval in 5 months for abemaciclib (Verzenio, Eli Lilly), a cyclin-dependent kinase (CDK) 4/6 inhibitor.
The agent also is approved for use in combination with fulvestrant for treatment of women with hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer whose disease progressed after endocrine therapy, and as monotherapy for adults with hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer whose disease progressed after endocrine therapy and prior chemotherapy in the metastatic setting.
The FDA based the new indication on results of the MONARCH 3 trial, presented at last year’s European Society for Medical Oncology Congress.
The double-blind, placebo-controlled, randomized phase 3 trial included 493 postmenopausal women with hormone receptor-positive, HER-2-negative advanced breast cancer who had received no prior systemic treatment for advanced disease.
Researchers assigned patients 2:1 to 150 mg abemaciclib or placebo orally twice a day, plus either 1 mg anastrozole or 2.5 mg letrozole once daily. Treatment continued until disease progression or unacceptable toxicity.
PFS served as the primary endpoint. Key secondary endpoints included objective response rate, duration of response, OS and safety.
As HemOnc Today previously reported, results showed patients who received abemaciclib 150 mg twice-daily plus an aromatase inhibitor achieved significantly longer median PFS than those who received placebo plus an aromatase inhibitor (28.2 months vs. 14.8 months; HR = 0.54; 95% CI, 0.41-0.69).
Among patients with measurable disease, researchers reported a higher ORR (55.4% vs. 40.2%) and longer median duration of response (27.4 months vs. 17.5 months) for those who received abemaciclib plus an aromatase inhibitor.
“This approval is an important milestone, as it shows that Verzenio plus an aromatase inhibitor substantially reduced tumor size and delayed disease progression in women with hormone receptor-positive, HER-2-negative metastatic breast cancer,” Joyce O'Shaughnessy, MD, chair of the breast cancer research program for Baylor University Medical Center, Texas Oncology and U.S. Oncology in Dallas, said in a press release. “This information will help inform treatment decisions for each patient, which can be complicated in advanced breast cancer.”
The most common adverse events reported in MONARCH 3 among women assigned abemaciclib plus anastrozole or letrozole included diarrhea (81% for combination vs. 30% for aromatase inhibitor plus placebo), neutropenia (41% vs 2%), fatigue (40% vs 32%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), increased creatinine (19% vs 4%) and constipation (16% vs 12%).
The most common grade 3 or grade 4 adverse events among women in MONARCH 3 were neutropenia (22% for combination vs. 2% for placebo), diarrhea (9% vs 1%), leukopenia (8% vs <1%), increased alanine aminotransferase (7% vs 2%) and anemia (6% vs 1%).