Eisai prepares ground for Halaven’s European launch
pharmafile | March 7, 2011 | News story | Sales and Marketing | Cancer, EMBRACE, Eisai, Halaven, advanced breast cancer, breast cancer, eribulin
Eisai has published further details of a phase III trial of its first-in-class chemotherapy drug Halaven ahead of its hoped-for European approval.
The FDA approved Halaven in November last year and Eisai’s drug was recommended by a European regulatory advisory committee in January.
Gearing up for a European launch it says is “impending”, the company has seen its EMBRACE study published in The Lancet.
This showed patients treated with Halaven (eribulin) survived a median of 13.1 months compared to 10.6 months for patients who were treated with a single-agent therapy.
“The publication of EMBRACE in The Lancet further reinforces the importance of Halaven as a potential new treatment for patients with metastatic breast cancer,” said Uday Bose, head of institutional care at Eisai Europe.
“These data open the door for a new treatment strategy in Europe, and one that will benefit patients who previously had very limited options. We are looking forward to the potential forthcoming authorisation of Halaven in Europe.”
Current treatments for advanced metastatic breast cancer include Roche’s Xeloda, in combination with docetaxel, after failure of prior anthracycline-containing chemotherapy.
Halaven has been submitted to the EMA with a monotherapy indication to treat patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.
But it could potentially be used at an earlier stage of treatment as a second trial is ongoing that compares the drug to Xeloda in women as a first or second line treatment.
This could help Eisai offset the forthcoming patent loss on Aricept, its biggest-selling drug, and gain a strong market position in a hard to treat cancer.
Lonnel Coats, chief executive of Eisai, said he was pleased to see these “compelling data” about Halaven in The Lancet.
“The availability of this new treatment option reinforces our human health care mission to produce therapies that can help make a difference in the lives of patients and their families,” he said.
Ben Adams
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