The news is a boost for the Spanish biotech company, which  already sells Yondelis as a treatment for soft tissue sarcoma,  a rare disease, and now hopes to address a much bigger  commercial opportunity. Bradley Monk, an oncologist from the University of  California Irvine Medical Center who led a Phase III trial of  the drug, said Yondelis could be added to a short list of  active drug therapies for recurrent ovarian cancer. “These are exciting results because positive trials in  recurrent ovarian cancer are rare and have almost always led to  federally approved treatments,” Monk said in a statement. “This treatment undoubtedly will be evaluated carefully by  the U.S. Food and Drug Administration and, if approved, will  give women with ovarian cancer another much-needed option.”    Zeltia’s drug, which it is developing with Johnson &  Johnson, is unusual in that it is a synthetic version of a  compound isolated from a type of sea squirt, a tubular marine  animal. It works by binding to the DNA of cancer cells and  blocking their ability to multiply. At 1445 GMT, Zeltia shares were down 5.4 percent at 5.43  euros, regaining ground after a low of 4.99 euros, while  Spain’s IBEX-35 blue chip index dropped 4.1 percent. “The stock’s had a good run. This news is already in the  price,” a Madrid-based trader said. The Spanish company had already announced that Yondelis,  its first product to reach the market, had shown positive  results in the pivotal trial. But the actual results of the study, involving 672 women  whose ovarian cancer had progressed after first-line treatment,  were only disclosed at the annual meeting of the European  Society of Medical Oncology (ESMO) in Stockholm. Monk said the results showed those women given a  combination of Yondelis and Johnson & Johnson’s chemotherapy  drug Doxil had no progression of their cancer for an average of  7.3 months, against 5.8 months for women treated only with  Doxil. In the case of women who had relapsed more than six months  after getting first-line therapy, the median progression-free  time was 9.2 months with Yondelis versus 7.5 months. In common with other anti-cancer agents, this suggests  Yondelis is most active in patients who have gone a long time  since receiving initial chemotherapy treatment. Zeltia plans to submit Yondelis for approval in Europe in  the fourth quarter of this year. Johnson & Johnson is expected  to file in the United States by the end of the year as well. The Spanish group has previously estimated that peak sales  of Yondelis for ovarian cancer could be around 300 million  euros ($420 million) in the European Union alone. Sales of the drug as a treatment for soft tissue sarcoma  are forecast to be about 30 million euros this year. Yondelis, whose generic name is trabectedin, is currently  approved for soft tissue sarcoma in Europe but not the U.S. The product is also being studied in smaller, Phase II  trials for prostate, breast and childhood cancers.
Zeltia drug delays progression of ovarian cancer.