BC Week In Review | Dec 22, 2017
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...
BC Week In Review | Nov 7, 2016
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...
BC Week In Review | Aug 15, 2016
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...
BC Week In Review | May 30, 2016
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...
BC Week In Review | May 16, 2016
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...
BC Week In Review | Apr 25, 2016
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...
BC Week In Review | Mar 7, 2016
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...
BC Week In Review | Feb 22, 2016
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...
BC Week In Review | Feb 8, 2016
Clinical News

Halaven eribulin mesylate regulatory update

FDA approved an sNDA from Eisai for Halaven eribulin mesylate to treat unresectable or metastatic liposarcoma in patients who have received a prior anthracycline-containing regimen. The synthetic analog of halichondrin B was under Priority Review...
BC Week In Review | Dec 21, 2015
Clinical News

Mifepristone: Additional Phase I/II data

Data from 13 evaluable patients with glucocorticoid receptor ( GCCR )-positive metastatic triple-negative breast cancer (TNBC) in an open-label, dose-escalation, U.S. Phase I/II trial showed that once-daily 300 mg mifepristone plus 1.1 mg/m 2 Halaven eribulin...
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