Ovarian Cancer Treatment
posted in Cancer |The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA), has decided to authorize the use of Spanish antitumor Yondelis for tumors of recurrent ovarian cancer. Bag reactions have not been expected and the Spanish company which markets, Zeltia, has seen its shares rise 36.7%, putting its price 4.91 euros.
In a press conference shortly after the news, the president of Zeltia, Jose Maria Fernandez Sousa, announced that the drug may be available in two to two and a half months in our country (for lack of final approval of the European Commission). In other European countries take a little longer until the price is negotiated with governments.
With many references to the economic impact that this decision will have on the Spanish company, Sousa predicted that the drug will be three or four times higher in terms of sales it is today for the treatment of sarcomas. Although it has acknowledged that the adoption does not lead away altogether the need for a capital increase, “What will we do if we need it, although it will be at most 2%,” he explained.
Yondelis is the trading name of trabectedin, ET-743 or as named in the laboratory. It is a synthetic derivative of a marine compound, the ‘Ecteinascidia turbinata’, already used in European countries at present for the treatment of other cancer, soft tissue sarcoma. Can also be used via the compassionate use (where no alternative therapy) to treat ovarian tumors that relapsed despite receiving other standard therapy after platinum-based or taxane. In the U.S., the product is considered an ‘orphan medicine’, which means that oncologists can administer it to patients who have no other therapeutic indication, but not formally adopted in either case.
However, the official decision of the Agency on its use for women with ovarian cancer and platinum-sensitive relapse (adopted by 32 votes to none against) was widely expected since early morning. Especially after his American counterpart (FDA, according to its acronym in English), rejected this authorization this summer claiming that the drug did not show improvement in overall survival for these women and gave certain cardiovascular and hepatic risks (problems no allusion to the EMEA).
Hence, both Sousa as the CEO of Paramour, Luis Mora, have spared no criticism when assessing the performance of the FDA, citing two recent articles (in the Wall Street Journal and The New YORW Times) , which also has challenged this rejection.
“The inexplicable is what has happened in the U.S., what everyone expected was what happened in Europe,” they said. While forecasted that “in a few months may be that the only country in the world where there is available is America.”
The trial OVA-301
The work that the Spanish subsidiary of Zeltia put on the table at the end of 2008 to secure this new indication in the European continent is the ET743-OVA-301, a test that compared the evolution of 672 women treated only half with Doxil and half with a combination of Yon delis and Doxil (liposome doxorubicin). The participants came from 138 hospitals in 21 countries around the world (including a small percentage of Spanish).
In the study, patients receiving Yondelis soon fall 7.3 months versus 5.8 in the other group. A fact that the FDA has not considered enough in America, so wait for overall survival data before returning to their comments. Something that can take between 18 and 24 months in the case, because, as explained by Sousa, “the best address women treated later in these deaths occur.”
The treatment of recurrent ovarian cancer will have a cost similar to sarcoma, 25,000 euros per patient, according to the company. It is an injectable substance, hospital use and administered in three-hour infusion for three weeks.
It is estimated that in Europe are diagnosed with ovarian tumors are 45,000 per year, of which 70% respond to platinum. Of these, about 3,500 are Spanish. To date, according PharmaMar, about 1,000 women have already received Yondelis for this disease in several clinical trials with a good safety profile.
Impact on the hardwood
The decision of the EMEA has resulted in a rise in shares of Zeltia of 36.7%, which has placed its stock price in euros 4.91, reports Europa Press.
The National Securities Market Commission (CNMV) had suspended trading of the drug before the opening of markets and lifted on 12.30. Furthermore, the extended the static range of pharmaceutical twice, up to 25% and then 40%, to encourage the trading of the company.
After an adjustment period, the company has returned at 1305 hours with heavy spikes, which placed its shares to 4.91 euros against 3.59 euros which marked the close of yesterday. After a few minutes of trading, the company maintained its strong rise, although somewhat more moderate, bringing the price of its shares at around € 4.80.