BC Week In Review | May 9, 2016
Company News

PharmaMar sales and marketing update

The U.K.’s NICE issued final guidance recommending against the use of Yondelis trabectedin from PharmaMar to treat the first recurrence of platinum-sensitive ovarian cancer. The agency said that the evidence did not show added benefit...
BC Week In Review | Dec 21, 2015
Company News

J&J, PharmaMar sales and marketing update

The U.K.’s NICE issued preliminary draft guidance recommending Johnson & Johnson’s Caelyx pegylated liposomal doxorubicin as monotherapy or in combination with platinum to treat recurrent ovarian cancer. The guidance recommends against Caelyx in combination with...
BC Week In Review | Nov 9, 2015
Clinical News

Yondelis trabectedin regulatory update

FDA approved an NDA from Johnson & Johnson’s Janssen Research & Development LLC unit for Yondelis trabectedin to treat unresectable or metastatic liposarcoma or leiomyosarcoma in patients who received a prior anthracycline-containing regimen. The cytotoxic...
BC Week In Review | Oct 19, 2015
Clinical News

Yondelis trabectedin regulatory update

Japan approved Yondelis trabectedin from Taiho to treat soft tissue sarcoma (STS). Yondelis is approved in Europe and outside the U.S. to treat relapsed platinum-sensitive ovarian cancer in combination with Caelyx pegylated liposomal doxorubicin and...
BC Week In Review | Oct 12, 2015
Clinical News

Yondelis trabectedin: Updated Phase III data

Updated data from the open-label, international Phase III SAR3007 trial in 577 patients with advanced liposarcoma or leiomyosarcoma who were previously treated with an anthracycline and >=1 additional chemotherapy regimen showed that 1.5 mg/m 2...
BC Week In Review | Sep 28, 2015
Clinical News

Yondelis trabectedin: Phase II started

PharmaMar said investigators began the open-label, European Phase II EORTC 1320 trial to compare 1.5 mg/m 2 IV Yondelis every 3 weeks vs. the standard of care based on the local investigator’s discretion in about...
BC Week In Review | Sep 21, 2015
Clinical News

Yondelis trabectedin: Additional Phase II data

An NDA for Yondelis is under Priority Review in the U.S. to treat advanced STS in patients who have received prior chemotherapy, including an anthracycline. The drug is marketed in 78 countries to treat advanced...
BC Week In Review | Jun 22, 2015
Clinical News

Yondelis trabectedin: Interim Phase III data

Interim data from the open-label, international Phase III SAR3007 trial in 518 patients with advanced liposarcoma or leiomyosarcoma who were previously treated with an anthracycline and >=1 additional chemotherapy regimen showed that 1.5 mg/m 2...
BC Week In Review | Jun 22, 2015
Clinical News

Yondelis trabectedin: Interim Phase II data

Interim data from the open-label, Italian Phase II ATREUS trial showed that 7 of 17 evaluable patients with biphasic/sarcomatoid MPM who received 1.3 mg/m 2 IV Yondelis every 3 weeks were alive and free of...
BC Week In Review | Feb 23, 2015
Clinical News

Yondelis trabectedin regulatory update

FDA accepted and granted Priority Review to an NDA from Johnson & Johnson’s Janssen Research & Development LLC unit for Yondelis trabectedin to treat advanced soft tissue sarcoma (STS) in patients who have received prior...
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