HALAVEN SUMMARY
HALAVEN (eribulin mesylate) Injection is a non-taxane microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.
HALAVEN is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two 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.
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NEWS HIGHLIGHTS
Published Studies Related to Halaven (Eribulin)
Eribulin mesylate versus ixabepilone in patients with metastatic breast cancer: a
randomized Phase II study comparing the incidence of peripheral neuropathy. [2013] Peripheral neuropathy is a common toxicity associated with tubulin-targeted
chemotherapeutic agents. This Phase II study compares the incidence and severity
of neuropathy associated with eribulin mesylate or ixabepilone in metastatic
breast cancer (MBC).Onset of neuropathy tended to occur later with eribulin and resolve
later.
Eribulin mesylate for the treatment of patients with refractory metastatic breast
cancer: use of a "physician's choice" control arm in a randomized approval trial. [2012] This work describes the considerations that led to the approval by the U.S. Food
and Drug Administration (FDA), on November 15, 2010, of eribulin mesylate
(Halaven; Eisai, Inc.) for the treatment of patients with refractory metastatic
breast cancer...
Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients
with locally recurrent or metastatic breast cancer. [2010] Eribulin mesylate (E7389) is a nontaxane microtubule dynamics inhibitor with a
novel mechanism of action...
Eribulin, a simplified ketone analog of the tubulin inhibitor halichondrin B, for
the potential treatment of cancer. [2007] Eisai Co Ltd is developing eribulin, a simplified synthetic macrocyclic ketone
analog of the tubulin inhibitor halichondrin B, for the potential treatment of
cancer. Phase III trials are underway in the US and Europe for patients with
breast cancer.
Clinical Trials Related to Halaven (Eribulin)
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function [Completed]
This is an open-label non-randomized study in subjects with advanced or metastatic solid
tumors who are no longer responding to available therapy. HALAVEN will be administered to
subjects on Days 1 and 8 of a 21-day cycle.
Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer [Completed]
This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory
pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with
operable Stage III HER2 non-overexpressing breast cancer.
Study of Eribulin in Children With Cancer to Determine Safety [Recruiting]
This is a study for children with cancer with no curative treatment options. The
investigators will be giving eribulin, a new chemotherapy agent, for the first time to
children. This study is designed to determine a safe dose the investigators can give to
children in larger studies. The investigators will be monitoring the children on this study
for the safety of the treatment and levels of eribulin in the blood after treatment. The
investigators will also study the effect of the agent on the cancer.
Halaven Post-Marketing Surveillance (PMS) [Recruiting]
Neuropharmacokinetics of Eribulin Mesylate in Treating Patients With Brain Metastases From Breast, Bladder, or Non-small Cell Lung Cancer [Recruiting]
This pilot trial studies the brain concentration of eribulin mesylate in treating patients
with breast, bladder, or non-small cell lung cancer that has spread to the brain
(metastases). Drugs used in chemotherapy, such as eribulin mesylate, work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Collecting small samples of brain fluids may
help determine how well eribulin mesylate concentrates into the brain tumor.
Reports of Suspected Halaven (Eribulin) Side Effects
Neutropenia (61),
Leukopenia (57),
Febrile Neutropenia (45),
Interstitial Lung Disease (40),
Pneumonia (31),
Pyrexia (23),
Stomatitis (18),
Nausea (18),
Fatigue (17),
Thrombocytopenia (17), more >>
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Page last updated: 2014-11-30
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