Product
Halaven
Approval Date
November 15, 2010
Release Date
November 25, 2010
Company
Eisai Pharmaceuticals
Class
Non-taxane, microtubule dynamics inhibitor
Indication
Treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease
Active Ingredient
Eribulin mesylate
Agency Roster
Biolumina Group
Marketing Strategy/Execution
Halaven, a breast cancer drug derived from sea sponges, is being leveraged by Eisai’s existing full-scale oncology infrastructure. Utilizing its in-house sales force on the roll-out, the firm has commenced independent marketing in the US, with sales promotion in community oncology clinics and academic institutions. Eisai reports positive initial impressions by physicians and payers as seen by early formulary placement and request for insurance verifications. Halaven is the first single agent to show overall survival benefit in third-line metastatic breast cancer patients, and the company is aiming for global peak sales of over $2 billion, based on anticipated approval by other countries and additional indications, including second-line use. About 200,000 women are newly diagnosed with advanced breast cancer each year (a million worldwide), and approximately 40% develop locally advanced or metastatic disease, per Eisai estimates.
Physician Outlook
With the increasing number of metastatic breast cancer patients undergoing four and more lines of treatment, high unmet needs exist for an efficacious and well tolerated treatment option for this heavily pretreated patient population. Halaven is the first new drug the FDA has approved for breast cancer in more than three years (and maybe the last novel chemo agent to become available for many years). It certainly has gained the oncologists’ attention and is considered as one of the notable cancer advances for 2010.
-Petra Maertens, director of syndicated studies, oncology, GfK HealthCare
Also in the Pipeline (courtesy of Adis R&D Insight)
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Source: Wolters Kluwer Pharma Solutions
Adverse Reactions
Neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, constipation, febrile neutropenia; possible QT prolongation, elevated liver enzymes.
Adults
Give by IV injection over 2–5 minutes. 1.4mg/m² on Days 1 and 8 of a 21-day cycle. Mild hepatic impairment (Child-Pugh A) or moderate renal impairment (CrCl 30–50mL/min): 1.1mg/m² on days 1 and 8 of a 21-day cycle. Moderate hepatic impairment (Child-Pugh B): 0.7mg/m² on Days 1 and 8 of a 21-day cycle. Hold dose for ANC <1000/mm³, platelets <75000/mm³, or grade 3 or 4 non-hematological toxicities. Delay or reduce dose according to toxicities; see literature. Do not re-escalate dose after it is reduced.
Children
Not recommended.
Precautions
Monitor CBCs; increase frequency of monitoring if grade 3 or 4 cytopenias develop, delay and reduce subsequent doses if febrile neutropenia or grade 4 neutropenia lasting >7 days develops. Monitor for peripheral neuropathy; withhold dose if grade 3 or 4 peripheral neuropathy develops until resolution to grade 2 or less. Congenital long QT syndrome: avoid. CHF, bradyarrhythmias, electrolyte abnormalities: monitor ECG for prolonged QT interval. Correct electrolyte abnormalities (K+, Mg+) before treatment; monitor. Severe hepatic impairment (Child-Pugh C) or severe renal impairment (CrCl<30mL/min): insufficient data. Pregnancy (Cat. D), nursing mothers: not recommended.
Interactions
Caution with other drugs that prolong QT interval (eg, Class IA and III antiarrhythmics); monitor.
