Tuesday, September 10, 2013

Denmark Regulators reject Zaltrap and Avastin use in colorectal cancer for the third time

It was still a no from the Coordinating Council for the deployment of hospital medicine, KRIS , to take drugs Zaltrap and Avastin in use nationally for patients with colon and rectal cancer.

KRIS discussed at a meeting on Wednesday for the third time Danish Colorectal Cancer Group ( DCCG ) request to take the two medicines used to treat colorectal cancer.

KRIS treated first DCCG 's application at a meeting in April. This advice was skeptical of the two funds , which it believes has too little power and especially Zaltraps him too many side effects . KRIS believe that the average survival gain on Zaltrap of 1.4 months is too little and puts addition weight of the drug has such bad side effects that around one fourth of the patients want to be removed from the treatment.

KRIS ' announcement in April that the council wanted to clarify a number of questions from DCCG before it would take a final decision and DCCG was invited to KRIS ' meeting in June to deepen the group's application. The presentation exterminated not KRIS ' skepticism , and the council decided to refuse the national deployment of Zaltrap and Avastin as a standard treatment in the treating hospital departments .

It was DCCG and pharmaceutical company behind Zaltrap , Sanofi , to criticize KRIS to cut Danish colorectal cancer patients the possibility of new , life-prolonging treatment .

Based on an analysis of data from the so-called VELOUR study , which was presented at the World Congress on Gastrointestinal Cancer in July , bath DCCG once KRIS to consider Zaltrap and Avastin as a standard treatment for Danish colorectal cancer patients.

The analytical work was not enough to convince KRIS that at its meeting on Wednesday appeared to still refusing to recommend Zaltrap and Avastin as a standard treatment for colon and rectal cancer. KRIS ' Chairman Steen Werner Hansen says that KRIS not believe that the analysis of old data are considered to be scientifically necessary to take treatments in use. Will new data, DCCG reapply says Steen Werner Hansen.

KRIS also points out in its refusal that some data indicate that Zaltrap not equally effective for all patient types. Among others, the European Medicines Agency , EMA , in Zaltraps SPC emphasized that it seems that the effect is worse if the patient has taken Avastin.

If there is scientific data that can narrow groups in, KRIS reconsider the possibility of taking drugs in use nationally , says Steen Werner Hansen.

Avastin and Zaltrap are both recombinant anti-neoplastic antibodies. Avastin containing the substance bevacizumab , and Zaltrap containing the substance aflibercept . Avastin has been approved since 2005, while Zaltrap was approved by the EMA 4 February.under department's own budget.

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