Eisai marine sponge derived cancer drug approved in Europe
pharmafile | March 23, 2011 | News story | Sales and Marketing | Cancer, Eisai, Halaven, Halichondria okadai, breast cancer, eribulin mesylate
Eisai’s injectible breast cancer drug Halaven has been approved by European regulators.
The highly novel drug is made from a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai that is believed to work by inhibiting cancer cell growth.
Halaven (eribulin mesylate) has been licenced to treat patients with locally advanced or metastatic breast cancer who have already had at least two chemotherapy regimens.
These two regimens should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
The approval is based on the phase III EMBRACE trial that showed Halaven met its primary endpoint by increasing overall survival of 13.25 months over 10.65 months – a median of 2.5 months.
Eisai said it would launch the drug first in the UK and then other northern European countries including Germany.
The EU decision builds on Halaven’s FDA approval, which it received in November for the same licence.
These approvals are key for Eisai to help the Japanese pharma offset the forthcoming patent loss on Aricept, its biggest-selling drug, and gain a strong market position in a hard to treat cancer.
Earlier this month Eisai announced a 20% cut to its US workforce – part of its wider strategy to remove 900 jobs globally by 2016 due to loss of exclusivity on the Alzheimer’s drug.
Current treatments for advanced metastatic breast cancer include Roche’s Xeloda, in combination with docetaxel, after failure of prior anthracycline-containing chemotherapy.
Halaven could potentially be used at an earlier stage of treatment that its currently second-line indications. An ongoing trial is comparing the drug to Xeloda in women as a first or second line treatment.
Eisai is also conducting late stage clinical trials of the drug as a single agent therapy for breast cancer and investigating its potential in non-small cell lung cancer, sarcoma, and prostate cancer.
Ben Adams
Related Content
Geneos Therapeutics shares data from phase 1/2 trial for cancer vaccine
Geneos Therapeutics has announced that it has published positive safety, immunogenicity and efficacy data from …
FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment
AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan …
Curve Therapeutics’ CSO publishes research on HIF inhibition for cancer treatment
Curve Therapeutics has announced that its chief scientific officer, Professor Ali Tavassoli has published research …
