Verzenio now approved

Verzenio is indicated:

  • In combination with fulvestrant for women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced or metastatic breast cancer (MBC) with disease progression following endocrine therapy
  • As monotherapy for the treatment of adult patients with HR+, HER2− advanced or metastatic breast cancer (MBC) with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

Press Release

Lilly Receives U.S. FDA Approval of Verzenio™ (abemaciclib)

INDIANAPOLIS, October 4, 2017 - Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Verzenio™ (abemaciclib) in combination with fulvestrant for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer with disease progression following endocrine therapy, and as monotherapy for the treatment of adult patients with HR+, HER2− advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. It is the first and only CDK4 & 6 inhibitor FDA approved in combination with fulvestrant and as monotherapy.1 The approval of Verzenio was received on September 28, 2017.

Verzenio is a cyclin-dependent kinase (CDK)4 & 6 inhibitor that will be available as 50, 100, 150 and 200 mg tablets. The recommended dose of Verzenio, in combination with fulvestrant, is 150 mg orally twice daily. As a monotherapy, the recommended dose of Verzenio is 200 mg orally twice daily. Both doses are recommended to be continued until disease progression or unacceptable toxicity occurs.1

“In recent years, CDK4 & 6 inhibitors have evolved treatment expectations for those with metastatic breast cancer. Nevertheless, there is still a need for new agents to treat estrogen-receptor positive breast cancer, like Verzenio,” said George W. Sledge Jr., M.D., professor of medicine, Stanford University School of Medicine and MONARCH 2 principal investigator. “Today’s approval represents an important development for our patients, who are dealing with the uncertainty of breast cancer progression.”

Read the full press release here.

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Verzenio Savings Card

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Eligible patients can receive the first 3 months of Verzenio FREE*

After the first 3 months, patients pay no more than $10 per month. If eligible, the Verzenio Savings Card covers the remainder of a patient’s out-of-pocket costs, up to a maximum of $25,000 over a 12-month enrollment period.*†

The Verzenio Savings Card is available to eligible, commercially insured patients.

  • Each card has a unique ID number.
    Please do not make copies.

Download now or get the Verzenio Savings Card(s) via email.

  • or

*This offer is invalid for patients whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program. Offer may be subject to a monthly and annual cap of wholesale acquisition cost plus usual and customary pharmacy charges.

†Eligibility Criteria

Verzenio Continuous Care Program

Patient support throughout her metastatic breast cancer journey

Verzenio Continuous Care logo

The Verzenio Continuous Care program was created to give patients personalized support and help provide a positive experience while taking Verzenio.

Each patient has access to a Continuous Care Team, which consists of a Reimbursement Specialist and a Companion in Care*, who will serve as dedicated resources and provide individualized support.

Access and financial assistance

The Reimbursement Specialist may assist with:

  • Helping eligible patients minimize co-pay or out-of-pocket costs by conducting a benefits investigation, guidance through the specialty pharmacy process, and more
  • Assisting office staff with resources to guide patients through the appeals process

Ongoing services

The Companion in Care will assist with:

  • Reiterating Verzenio treatment information (like dosing and adverse events) that you’ve outlined in your office
  • Guiding patients back to your office if they are experiencing side effects or have questions regarding their treatment
  • Connecting patients with advocacy groups

Download this form to enroll your patients or call 1-844-VERZENIO (1-844-837-9364) to learn more about Verzenio Continuous Care.

*The Companion in Care is not a doctor or nurse, or a substitute for a medical professional; the Companion in Care will direct the patient to her healthcare provider for medical advice.

Indication

Verzenio is indicated:

  • In combination with fulvestrant for women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2−) advanced or metastatic breast cancer (MBC) with disease progression following endocrine therapy
  • As monotherapy for the treatment of adult patients with HR+, HER2− advanced or metastatic breast cancer (MBC) with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

Important Safety Information

Diarrhea occurred in 86% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 90% of patients receiving Verzenio alone in MONARCH 1. Grade 3 diarrhea occurred in 13% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 20% of patients receiving Verzenio alone in MONARCH 1. Episodes of diarrhea have been associated with dehydration and infection.

In MONARCH 2, diarrhea incidence was greatest during the first month of Verzenio dosing. The median time to onset of the first diarrhea event was 6 days, and the median duration of diarrhea for Grades 2 and 3 were 9 days and 6 days, respectively. Twenty-two percent of patients with diarrhea required a dose omission and 22% required a dose reduction. In the MONARCH 1 study, the time to onset and resolution for diarrhea were similar to those in MONARCH 2.

Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy such as loperamide, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.

Neutropenia occurred in 46% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 37% of patients receiving Verzenio alone in MONARCH 1. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 32% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 27% of patients receiving Verzenio in MONARCH 1. In MONARCH 2 and MONARCH 1, the median time to first episode of Grade >3 neutropenia was 29 days, and the median duration of Grade ≥3 neutropenia was 15 days.

Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Febrile neutropenia has been reported in 1% of patients exposed to Verzenio in MONARCH 2 and MONARCH 1. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.

Grade ≥3 increases in alanine aminotransferase (ALT) (4% versus 2%) and aspartate aminotransferase (AST) (2% versus 3%) were reported in the Verzenio and placebo arms respectively, in MONARCH 2.

In MONARCH 2, for patients receiving Verzenio plus fulvestrant with Grade ≥3 ALT increased, median time to onset was 57 days, and median time to resolution to Grade <3 was 14 days. For patients with Grade ≥3 AST increased, median time to onset was 185 days, and median time to resolution was 13 days.

For assessment of potential hepatotoxicity, monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or Grade 3 or 4, hepatic transaminase elevation.

Venous thromboembolic events were reported in 5% of patients treated with Verzenio plus fulvestrant in MONARCH 2 as compared to 0.9% of patients treated with fulvestrant plus placebo. Venous thromboembolic events included deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis. Across the clinical development program, deaths due to venous thromboembolism have been reported. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate.

Verzenio can cause fetal harm when administered to a pregnant woman based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for at least 3 weeks after the last dose. There are no data on the presence of Verzenio in human milk or its effects on the breastfed child or on milk production. Advise lactating women not to breastfeed during Verzenio treatment and for at least 3 weeks after the last dose because of the potential for serious adverse reactions in breastfed infants. Based on findings in animals, Verzenio may impair fertility in males of reproductive potential.

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 2 for Verzenio plus fulvestrant and ≥2% higher than placebo plus fulvestrant were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 3%), thrombocytopenia (16% vs 3%), alopecia (16% vs 2%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4%), pyrexia (11% vs 6%), and weight decreased (10% vs 2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), leukopenia (17%), constipation (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm of MONARCH 2 were neutropenia (27% vs 2%), diarrhea (13% vs <1%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (6% vs 3%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were neutropenia (24%), diarrhea (20%), fatigue (13%), infections (7%), leukopenia (6%), anemia (5%), and nausea (5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for Verzenio plus fulvestrant and ≥2% higher than placebo plus fulvestrant were increased serum creatinine (98% vs 74%; 1% vs 0%), decreased white blood cells (90% vs 33%; 23% vs 1%), decreased neutrophil count (87% vs 30%; 33% vs 4%), anemia (84% vs 33%; 3% vs <1%), decreased lymphocyte count (63% vs 32%; 12% vs 2%), decreased platelet count (53% vs 15%; 2% vs 0%), increased ALT (41% vs 32%; 5% vs 1%), increased AST (37% vs 25%; 4% vs 4%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were increased serum creatinine (98%; <1%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 27%), anemia (68%; 0%), decreased lymphocyte count (42%; 14%), decreased platelet count (41%; 2%), increased ALT (31%; 3%), and increased AST (30%; 4%).

Strong CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of other strong CYP3A inhibitors. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of other strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the strong inhibitor. Patients should avoid grapefruit products.

Avoid concomitant use of strong CYP3A inducers and consider alternative agents. Coadministration of Verzenio with rifampin, a strong CYP3A inducer, decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.

With severe hepatic impairment (Child-Pugh Class C), reduce the Verzenio dosing frequency to once daily. The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr ≥30-89 mL/min).

Please see full Prescribing Information for Verzenio.

AL HCP ISI 02OCT2017

1 Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.