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FDA approves eribulin for advanced liposarcoma


 

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The Food and Drug Administration has approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

The approval was based on improved overall survival (OS) in an open-label, randomized, multicenter trial of 446 patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who had received at least two prior systemic chemotherapies (one of which must have included an anthracycline) and had experienced disease progression within 6 months of randomization, according to the Jan. 28 statement issued by the FDA.

Patients were randomized to receive either eribulin 1.4 mg/m2 on days 1 and 8 of a 21-day cycle or dacarbazine (at a dose of 850 mg/m2, 1,000 mg/m2, or 1,200 mg/m2 chosen by the investigator prior to randomization) on day 1 of a 21-day cycle.

Eribulin benefit was limited to the subgroup of patients with liposarcoma. The median OS was 15.6 vs. 8.4 months (HR 0.51 [95% CI: 0.35, 0.75]) and the median progression-free survival (PFS) was 2.9 vs. 1.7 months (HR 0.52 [95% CI: 0.35, 0.78]) in patients with liposarcoma treated with eribulin compared to dacarbazine, respectively. There was no evidence of efficacy for eribulin in patients with leiomyosarcoma.

The most common adverse reactions among those who received eribulin in the trial were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common grade 3-4 laboratory abnormalities were neutropenia, hypokalemia, and hypocalcemia.

The most common serious adverse reactions were neutropenia (4.9%) and pyrexia (4.5%). Febrile neutropenia occurred in 0.9% and fatal neutropenic sepsis in 0.9% of patients treated with eribulin. The most frequent adverse reactions leading to discontinuation were fatigue (0.9%) and thrombocytopenia (0.9%), according to the FDA statement.

Eribulin is marketed as Halaven injection by Eisai. The recommended dose and schedule for eribulin is 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.

lnikolaides@frontlinemedcom.com

On Twitter @nikolaideslaura

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