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EUROPA E USA DIVISE SULL'AVASTIN. FDA: "STOP ALL'USO PER I TUMORI AL SENO"

The American authorities had withdrawn from the Swiss drug therapies for breast cancer, the Ema instead saves the "validity" limited to situations in combination with paclitaxel chemotherapy. Roche defends the product and request a hearing of appeal, but analysts said the U.S. decision could cost from one to six billion dollars a year in lost sales

ADELE SARNO

Europe and the United States are divided sull'Avastin, cancer of the tip of the Roche often used against breast cancer. If in fact the U.S. Food and Drug Administration (FDA), the American agency for the drug, has decided to eliminate from the therapeutic indications of Avastin (the name of the active molecule) that relating to breast cancer, in the old Continent, things went differently.


The European Medicines Agency (EMA) in a statement one is in favor of the product: "The benefits of Avastin in combination with paclitaxel, a chemotherapy drug, outweigh the risks. This combination is a useful therapeutic option for patients with metastatic breast cancer. " Deleted but the association with docetaxel, a chemotherapy, according to the EMA is not able to improve the life expectancy of patients.

Experts from FDA, already in July, had questioned two dell'Avastin administration in the treatment of breast cancer with metastases. The FDA had used in support of its argument, the results of clinical trials that the drug was not able to guarantee the survival or the lengthening of life, and could have very serious side effects: hypertension, bleeding and perforation of parts the body as the nose, stomach and intestine.

The FDA, therefore, proposed the withdrawal of the product because the benefits were not sufficient to justify its use in the treatment of breast cancer metastases in women undergoing chemotherapy. Today, the American Association for the drug agency's decision has become final. In fact in the U.S. on the box dell'Avastin will be deleted, from indications, that of breast cancer while the tumor remains the intestines, kidneys and lungs. The

Ema, usually pretty true to the FDA decision, this time went on their own, saving the "validity" of the drug against breast cancer as the only treatment where it is combined with Taxol chemotherapy. The Committee for Medicinal Products per uso umano dell'Ema ha concluso che l'Avastin in combinazione con paclitaxel (il principio attivo del Taxol) continua a produrre benefici superiori ai rischi "perché i dati disponibili hanno dimostrato in modo convincente di prolungare la sopravvivenza libera da progressione di pazienti con tumore della mammella senza un effetto negativo sulla sopravvivenza totale".

Ciò che l'Ema ha bocciato è il trattamento combinato con il Taxotere (docetaxel il principio attivo), un agente chemioterapico usato per il trattamento di alcune forme tumorali. "La combinazione Avastin e docetaxel - si legge nella nota ufficiale - non deve più essere utilizzata nel trattamento del carcinoma mammario. I pazienti che sono attualmente in trattamento con this combination should re-examine the current treatment with their doctor. "therapy in question was approved in September 2009 based on data that showed a small but significant increase in survival. The new data submitted to the Agency have not ruled out negative effects on their chances of survival to the tumor.

La Roche continues to defend its product 3 and asked the FDA hearing to challenge the decision. According to some analysts, the multinational pharmaceutical industry could lose between one billion dollars annual sales with the position taken by the FDA. The Avastin is used in Italy only 10% of cases of breast cancer, but in the U.S. so far has been a drug utilizzatissimo. Remains a flagship product of Roche (13% of its sales in 2009) and analysts predicted that in 2014 would become the biggest selling prescription drug in the world, with sales of $ 9 billion annually.

SOURCE: The repubblica.it