NICE rejects Yondelis in ovarian cancer
pharmafile | June 21, 2010 | News story | Sales and Marketing | NICE, PharmaMar, Yondelis, ovarian cancer
New cancer treatment Yondelis has been rejected by NICE in a preliminary ruling on its use in relapsed ovarian cancer.
NICE says the manufacturer PharmaMar has not submitted sufficient evidence that the drug helps patients more than established treatments.
Yondelis (trabectedin) was assessed in combination with pegylated liposomal doxorubicin (PLDH) for the treatment of relapsed ovarian cancer that is sensitive to platinum-based therapies.
The data submitted by PharmaMar did not compare Yondelis against the current ‘gold-standard’ treatment for relapsed ovarian cancer, paclitaxel, in combination with platinum-based chemotherapy.
NICE’s committee said that because of this, it could not confirm whether or not it extends patients’ lives for longer than one of the more effective and commonly-used treatments for this form of cancer.
“In current clinical practice, paclitaxel in combination with platinum-based chemotherapy is widely regarded as one of the most effective treatments for women with platinum-sensitive, relapsed ovarian cancer,” said Sir Andrew Dillon, NICE’s chief executive.
He added: “The evidence did, however, show that trabectedin is associated with high rates of toxicity on the body’s blood system compared with other, currently available drugs. It was these factors and not necessarily the cost of the treatment that concerned the committee most.”
Sir Andrew added: “It’s important to remember that not everyone whose cancer has relapsed would be suitable for trabectedin. A range of treatment options do already exist for ovarian cancer and especially for tumours that have returned. In 2005, NICE approved a number of drugs shown to be effective in treating relapsed disease, including paclitaxel in combination with platinum-based chemotherapy, which is now one of the most widely used treatments in clinical practice.”
Ovarian cancer is the fifth most common cancer in women in the UK with nearly 6,600 women diagnosed with the disease each year. It is thought the cancer returns after initial treatment in around 80% of cases and just over two fifths of these patients would be eligible for trabectedin, if the drug were to be approved.
The preliminary guidance is available for public consultation until 9 July.
Yondelis is an intravenous drug that works by damaging the DNA in cancer cells, making the cells unable to grow and spread.
In February it won NICE approval to treat some patients with advanced soft tissue sarcoma.
Andrew McConaghie
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