U.S. FDA Approves YONDELIS® (trabectedin) for the Treatment of Liposarcoma or Leiomyosarcoma - Two Common Subtypes of Soft Tissue Sarcoma

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PharmaMar

23 Oct, 2015, 16:30 BST

MADRID, October 23, 2015 /PRNewswire/ --

PharmaMar announced today that its licensing partner, Janssen Biotech, Inc. received marketing approval for YONDELIS®(trabectedin) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) who have received a prior anthracycline-containing regimen. LPS and LMS are among the most common types of soft tissue sarcoma and this is the first treatment to be specifically approved for LPS in the U.S.


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The approval was based on the clinical efficacy and safety data from a recently published Phase 3, randomized, open-label, controlled study, ET743-SAR-3007, which evaluated YONDELIS® versus dacarbazine in this patient population[i]. This pivotal trial confirmed the results of previous clinical studies and provides strong evidence of the clinical benefit of trabectedin.

"Since YONDELIS® was first approved in Europe in 2007 approximately 50,000 patients in 80 countries have benefited from this therapy across all indications," says Luis Mora, Managing Director, PharmaMar, who added that "the approval in the U.S. will allow more patients with this disease to have access to a drug that will address an unmet medical need."

For the approval of YONDELIS® in the U.S., PharmaMar will receive the appropriate milestone from Janssen Products, LP.

About YONDELIS® (trabectedin)   

YONDELIS® (trabectedin) is a synthetically produced anti-tumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. It works by targeting the transcription machinery[ii] and impairing DNA repair[iii] in cancer cells, thus inducing tumor cell death. It is approved in 80 countries in North America, Europe, South America and Asia. Indications vary by country and include the treatment of advanced soft tissue sarcomas and relapsed ovarian cancer in combination with DOXIL®/CAELYX®. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS® globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceutical Co., Ltd.

i. http://jco.ascopubs.org/content/early/2015/09/14/JCO.2015.62.4734.full

ii. http://www.nature.com/bjc/journal/v111/n4/full/bjc2014149a.html  

iii. http://www.nature.com/nm/journal/v7/n8/full/nm0801_961.html

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SOURCE PharmaMar