FDA APPROVES EISAI’S HALAVEN® (ERIBULIN MESYLATE) INJECTION FOR THE TREATMENT OF PATIENTS WITH ADVANCED LIPOSARCOMA
Eisai is pleased to announce that HALAVEN® (eribulin mesylate) Injection (0.5 mg per mL) is now approved by the US Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.1 HALAVEN has been approved for the treatment of third-line metastatic breast cancer since 2010.1
HALAVEN is the first and only FDA-approved single agent to demonstrate an overall survival (OS) benefit in a Phase III study of patients with advanced liposarcoma.2 The approval was based on the results of the trial, which evaluated 446 patients with unresectable, locally advanced, or metastatic liposarcoma or leiomyosarcoma; at least 2 prior systemic chemotherapies (one of which must have included an anthracycline); and disease progression within 6 months of the most recent chemotherapy regimen. Patients were treated with HALAVEN or dacarbazine.1
The results showed that patients with advanced liposarcoma who received HALAVEN (n=71) experienced a median OS of 15.6 months (compared with 8.4 months for those treated with dacarbazine, n=72, hazard ratio=0.51 [95% confidence interval: 0.35, 0.75]).1
Progression-free survival (PFS), the secondary endpoint, was 2.9 months for patients with advanced liposarcoma who were treated with HALAVEN (compared with 1.7 months for those treated with dacarbazine, hazard ratio=0.52 [95% confidence interval: 0.35, 0.78]).1
In this study, HALAVEN demonstrated a statistically significant improvement in OS compared with dacarbazine. Median OS in all treated patients was 13.5 months with HALAVEN vs 11.3 months with dacarbazine (hazard ratio=0.75 [95% confidence interval: 0.61-0.94], P=0.011), and PFS was 2.6 months with HALAVEN vs 2.6 months with dacarbazine (hazard ratio=0.86 [95% confidence interval: 0.69-1.06). The treatment effects of HALAVEN were limited to patients with liposarcoma, based on pre-planned, exploratory subgroup analyses of OS and PFS. The efficacy of HALAVEN compared with dacarbazine in advanced or metastatic leiomyosarcoma was not demonstrated in this study.1
The adverse events seen in Study 309 were consistent with the known profile of HALAVEN. Serious side effects from treatment with HALAVEN may include neutropenia, peripheral neuropathy, embryo-fetal toxicity, and QT prolongation. The most common adverse reactions (incidence greater than or equal to 25%) in study patients with liposarcoma and leiomyosarcoma treated with HALAVEN were asthenia/fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). The most common serious adverse reactions reported in patients receiving HALAVEN were neutropenia (4.9%) and pyrexia (4.5%). The most common adverse reactions resulting in discontinuation of HALAVEN were fatigue and thrombocytopenia (0.9% each). Additional Important Safety Information including use in specific populations is presented below.1
Our commitment to patients is the driving force behind our discovery and development of therapies that help address unmet medical needs. This approval reinforces Eisai’s dedication to the development of treatments for rare and hard-to-treat diseases.2
At Eisai, we strive to provide patients with access to treatment options that may benefit them and work hard to ensure that our products can be obtained by those who need them. Patients can visit www.halavenreimbursement.com/savings to learn more about Eisai’s patient assistance services and reimbursement support programs.
Indications
Metastatic Breast Cancer
HALAVEN is indicated for the treatment of patients with metastatic breast cancer (mBC) who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Liposarcoma
HALAVEN is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Important Safety Information
Warnings and Precautions
Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.
Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.
QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
Adverse Reactions
In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).
In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).
Use in Specific Populations
Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.
Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.
Please see the HALAVEN full Prescribing Information.
[su_button url=”https://drive.google.com/file/d/0B6-Dl5zKUz0DRkE3enRFajBlVWM/view?usp=sharing” target=”blank” style=”glass” background=”#0000ff” color=”#fafafa” size=”7″ center=”yes” icon=”icon: arrow-circle-right” icon_color=”#fafafa” text_shadow=”0px 0px 0px #fafafa”]View Release Here[/su_button]
