17:57 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Polyphor reports Phase Ib data for breast cancer candidate

Polyphor Ltd. (Allschwill, Switzerland) reported data from an open-label, dose-escalation Phase Ib trial in 54 women with previously treated HER2-negative, CXC chemokine receptor 4 (CXCR4; NPY3R)-positive metastatic breast cancer showing that IV balixafortide (POL6326) plus...
19:25 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

Eisai reports Phase Ib/II data for Halaven plus Keytruda in TNBC

Eisai Co. Ltd. (Tokyo:4523) reported data from 106 evaluable patients with metastatic triple-negative breast cancer (TNBC) in the Phase Ib/II ENHANCE 1 (KEYNOTE-150) trial showing that Halaven eribulin mesylate (E7389) plus anti-PD-1 mAb Keytruda pembrolizumab...
23:14 , Nov 7, 2016 |  BC Week In Review  |  Company News

Halaven sales and marketing update

The U.K.’s NICE issued a final appraisal determination (FAD) recommending the use of Halaven eribulin mesylate to treat advanced or metastatic breast cancer in patients who have received ≥2 prior chemotherapy regimens. The agency said...
07:00 , Aug 15, 2016 |  BC Week In Review  |  Clinical News

Halaven eribulin mesylate regulatory update

China Food and Drug Administration (CFDA) accepted for review an NDA from Eisai for Halaven to treat locally advanced or metastatic breast cancer. The synthetic analog of halichondrin B compound is approved in over 60...
07:00 , Aug 8, 2016 |  BC Week In Review  |  Clinical News

PEGPH20: Phase Ib/II started

Halozyme and Eisai Co. Ltd. (Tokyo:4523, Tokyo, Japan) began an open-label Phase Ib/II trial to compare PEGPH20 plus Halaven eribulin vs. Halaven alone in about 96 patients. The Phase I portion will evaluate 1.6 and...
07:00 , May 30, 2016 |  BC Week In Review  |  Clinical News

Halaven eribulin mesylate: Phase III data

Top-line data from the open-label, Chinese Phase III Study 304 in 530 women with locally recurrent or metastatic breast cancer previously treated with 2-5 chemotherapy regimens, including an anthracycline and a taxane, showed that 1.4...
07:00 , May 16, 2016 |  BC Week In Review  |  Clinical News

Halaven eribulin mesylate regulatory update

The European Commission approved a label expansion for Eisai’s Halaven eribulin to include treatment of unresectable liposarcoma in adults who have received prior anthracycline-containing therapy for advanced or metastatic disease. The synthetic analog of halichondrin...
07:00 , Apr 25, 2016 |  BC Week In Review  |  Clinical News

Halaven eribulin mesylate regulatory update

EMA’s CHMP recommended expanding the label of Eisai’s Halaven eribulin to include treatment of unresectable liposarcoma in adults who have received prior anthracycline-containing therapy for advanced or metastatic disease. The synthetic analog of halichondrin B...
08:00 , Mar 7, 2016 |  BC Week In Review  |  Clinical News

Eribulin mesylate regulatory update

Eisai said Japan approved Halaven eribulin mesylate to treat soft tissue sarcoma (STS). The synthetic analog of halichondrin B is approved in Japan to treat unresectable or recurrent breast cancer. Halaven is approved in about...
08:00 , Feb 22, 2016 |  BC Week In Review  |  Company News

Piqur, Eisai deal

Piqur will conduct a Phase I/IIb trial combining breast cancer drug Halaven eribulin mesylate from Eisai with the biotech’s PQR309 to treat triple-negative breast cancer (TNBC). PQR309, a phosphoinositide 3-kinase (PI3K) and mammalian target of...