CHMP Recommends Eisai's Cancer Drug Label Change
Tokyo-based Eisai announced that its U.K. subsidiary Eisai Europe has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the indication expansion of anticancer agent Halaven (eribulin mesylate).
Halaven is a non-taxane, microtubule dynamic inhibitor with a new mechanism of action. The drug is a member of a class of antineoplastic agents called halichondrins, derived from the marine sponge Halichondria okadai. The drug is considered to work by inhibiting the microtubule dynamics growth phase while sparing the shortening phase and sequestering tubulin into nonproductive aggregates.
Eribulin’s currently approved indication in EU is treatment for patients with locally advanced or metastatic breast cancer which have progressed following at least two chemotherapeutic regimens for advanced disease. Prior therapy should include an anthracycline and a taxane unless deemed unsuitable. The CHMP recommended Eisai’s application to expand the current indication to include patients with metastatic breast cancer who have had less prior treatment.
The recommendation from the CHMP was supported by data from two pivotal Phase III studies comparing eribulin against Treatment of Physician’s Choice (PTC) in patients with local advanced or metastatic breast cancer who had previously undergone 2 to 5 chemotherapeutic regimens, including treatment with an anthracycline and a taxane. Positive data from a Phase III clinical study (Study 301) of eribulin compared to capecitabine in women with locally advanced or metastatic breast cancer who had received prior treatment with an anthracycline and a taxane also supported the positive CHMP opinion.
The drug is currently approved in the U.S. as a treatment for breast cancer and has received regulatory approval in more than 50 countries around the world including Japan, Switzerland, and Singapore. Eisai is currently advancing the drug into clinical investigation and development as potential therapy in breast cancer with fewer prior treatments as well as non-small cell lung cancer (NSCLC) and soft tissue sarcoma.