USA - FDA Panel Votes Against Yondelis for Ovarian Cancer

The US Food and Drug Administration (FDA) voted against recommending approval for Yondelis (trabectedin) for ovarian cancer in July 2009. The drug was submitted by partner Johnson & Johnson (J&J).

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-1 against approval of Zeltia’s Yondelis for the treatment of relapsed ovarian cancer, in combination with J&J’s Doxil/Caelyx (doxorubicin). The drug was shown to have a six-week benefit in progression-free survival in a Phase III trial, but the panel decided this does not justify the use of the drug.

The ODAC also noted that there was a notable increase in severe and life-threatening adverse events in the Yondelis treatment group, including more than twice as many pulmonary embolisms, three times more cardiac adverse events and a higher rate of liver enzyme increases.

J&J’s Centocor Ortho Biotech unit said that it still believes trabectedin “has an important role in the treatment of recurrent ovarian cancer” and “remains committed to working with the FDA to address the committee’s concerns".

Further reading - An in-depth analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)

UK - NICE Rejects Drug for Soft Tissue Carcinoma

NHS patients with advanced soft tissue carcinoma will not have access to Yondelis (trabectedin) because it is not cost-effective, the National Institute for Health and Clinical Excellence (NICE) ruled in July 2009.

Spanish drugmaker Zeltia’s Yondelis is an alkylating agent that damages the DNA of cancer cells.

Under new rules unveiled in January 2009, NICE is now more flexible when considering drugs for end-of-life care. However, despite agreeing that Yondelis meets the criteria for being a life-extending, end-of-life treatment which could increase patient survival by up to three months, NICE concluded that the benefits do not justify use of NHS resources as the drug is still not cost-effective.

A second appraisal committee meeting is scheduled for 4th August 2009, with comments on the consultation taken up until 21st July 2009.

Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)