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Halaven® (eribulin) for metastatic breast cancer (MBC)
Halaven is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai

Therapeutic indication:
Halaven is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.¹

 

 


Resources

Halaven (eribulin)

First Thoughts Breast Cancer Bitecast 27th Feb 2023 – On Demand

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Halaven (eribulin)

First Thoughts Breast Cancer Bitecast
21st Sept 2022 On Demand

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Halaven (eribulin)

First Thoughts Breast Cancer Bitecast 21st June 2022 On Demand

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Halaven (eribulin)

First Thoughts Breast Cancer Bitecast May 2022
On Demand

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Halaven (eribulin)

Patient Information Leaflet

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Halaven (eribulin)

Dosing & Administration Guide

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Halaven (eribulin)

EMPOWER Study Summary

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Halaven (eribulin)

Halaven at Home

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Halaven (eribulin)

Adverse Event Monitoring and Management Guide

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References: 1. Halaven Summary of Product Characteristics

UK-HAL-23-00007 Date of preparation January 2023

 

The primary endpoint of EMBRACE (N=762) was OS, PFS was a secondary endpoint1

  • Significantly longer OS with Halaven vs TPC: 13.1 months vs 10.6 months, respectively (HR, 0.81; 95% CI, 0.66–0.99; p=0.041)
  • In an updated, non-protocol-prespecified analysis (requested by European and US regulatory authorities), median OS was 13.2 months for Halaven vs 10.5 months for TPC (HR, 0.81; 95% CI, 0.67–0.96; nominal p=0.014)1
  • Median PFS was 3.7 months for Halaven vs 2.2 months for TPC (HR, 0.87; 95% CI, 0.71–1.05; p=0.137)
  • ORR was 12% for Halaven vs 5% for TPC
  • P-values are deemed nominal as the analysis was non-prespecified1

 

*Patients and investigators were not masked to treatment allocation.
†1.4 mg/m2 eribulin mesilate is equivalent to 1.23 mg/m2 eribulin.2
‡TPC was selected prior to randomisation to eliminate any bias. Treatments were approved for the treatment of cancer, but not necessarily MBC. 238 (96%) patients received chemotherapy (61 [25%] vinorelbine; 46 [19%] gemcitabine; 44 [18%] capecitabine; 38 [15%] taxanes; 24 [10%] anthracyclines; 25 [10%] other chemotherapies), 9 (4%) patients received hormonal therapy.1

AE: adverse event, CI: confidence interval, ECOG PS: Eastern Cooperative Oncology Group performance status, HR: hazard ratio, IV: intravenous, MBC: metastatic breast cancer. ORR: objective response rate, OS: overall survival, PFS: progression-free survival, TPC: treatment of physician’s choice.

References: 1. Cortes J, et al. Lancet. 2011;377(9769):914–923. 2. Kaufman PA, et al. J Clin Oncol. 2015;33(6):594–601. 3. ClinicalTrials.gov. Identifier: NCT00388726. Available from https://clinicaltrials.gov/ct2/show/study/NCT00388726 (accessed Jan 2023).

 

The co-primary endpoints of Study 301 (N=1102) were OS and PFS1

  • Median OS was not significantly longer with Halaven vs capecitabine: 15.9 and 14.5 months, respectively (HR, 0.88; 95% CI, 0.77–1.00; p=0.056)
  • Median PFS was 4.1 months for Halaven vs 4.2 months for capecitabine (HR, 1.08; 95% CI, 0.93–1.25; p=0.30)
  • ORR was 11.0% for Halaven vs 11.5% for capecitabine

*Patients stratified by geographic region (Latin America, Western Europe/Australia, Eastern Europe, North America, Asia or South Africa) and HER2 status (positive, negative or unknown).
†Patients with HER2-positive disease could have received HER2-targeted therapy before or after study treatment but not while on study treatment.
‡1.4 mg/m2 eribulin mesilate is equivalent to 1.23 mg/m2 eribulin.

AE: adverse event, b.d.: twice daily, CI: confidence interval, HER2: human epidermal growth factor receptor 2, HR: hazard ratio, MBC: metastatic breast cancer, IV: intravenous, ORR: objective response rate, OS: overall survival, PFS: progression-free survival.

References: 1. Kaufman PA, et al. J Clin Oncol. 2015;33(6):594–601. 2. Cortes J, et al. Lancet. 2011;377(9769):914–923.

 

UK-HAL-23-00008 Date of preparation January 2023

Halaven® safety profile

Summary of the safety profile of Halaven in the Summary of Product Characteristics1

The most commonly reported adverse reactions related to Halaven, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections. New onset or worsening of pre-existing peripheral neuropathy has also been reported. Gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, and stomatitis are among reported undesirable effects. Other undesirable effects include fatigue, alopecia, increased liver enzymes, sepsis and musculoskeletal pain syndrome.

Taken from Halaven Summary of Product Characteristics.1

*Incidence rates of adverse events observed in breast cancer and soft tissue sarcoma patients who received the recommended dose in Phase II and Phase III studies. Very common (≥1/10) and common (≥1/100 to <1/10) events only.
†Includes Grade 5 events.
‡No Grade 4 events. §Includes preferred terms of peripheral neuropathy, peripheral motor neuropathy, polyneuropathy, paraesthesia, peripheral sensory neuropathy, peripheral sensorimotor neuropathy and demyelinating polyneuropathy.

AE: adverse event.

 

<1% of patients discontinued due to haematological adverse events2

*Safety assessments were protocol prespecified and included the safety population (all patients randomly assigned to treatment groups who received either eribulin or TPC).
†Peripheral neuropathy includes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy, demyelinatingpolyneuropathy, and paraesthesia.

AE: adverse event, TPC: treatment of physician’s choice.

 

*Safety assessments were protocol prespecified and included the safety population (all patients randomly assigned to treatment groups who received either eribulin or TPC).
†Peripheral neuropathy includes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy, demyelinatingpolyneuropathy, and paraesthesia.

AE: adverse event, TPC: treatment of physician’s choice.

 

The only haematological adverse event to have a discontinuation rate of >1% was neutropenia (1.7%)3

AE: adverse event.

Adapted from Kaufman PA, et al. 2015.3
AE: adverse event.

References: 1. Halaven Summary of Product Characteristics. 2. Cortes J, et al. Lancet. 2011;377(9769):914–923. 3. Kaufman PA, et al. J Clin Oncol. 2015;33:594–601.

 

UK-HAL-23-00009 Date of preparation January 2023

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store, or Ireland www.hpra.ie. Adverse events should also be reported to Eisai Ltd on +44 (0)845 676 1400 / +44 (0)208 600 1400 or EUmedinfo@eisai.net

UK-HAL-23-00010 Date of preparation January 2023