Zeltia has suffered a major setback after an advisory panel to the US Food and Drug Administration overwhelmingly voted against recommending approval for Yondelis for ovarian cancer, following a submission by partner J&J.

The FDA’s Oncologic Drugs Advisory Committee voted 14-1 against approval of Yondelis (trabectedin) for the treatment of relapsed ovarian cancer, in combination with J&J’s Doxil/Caelyx (doxorubicin). The panel has decided that the six-week benefit in progression-free survival shown in a Phase III trial does not justify the green light for the drug and the FDA usually follows these recommendations, though it does not have to.

The ODAC pointed out there was a notable increase in severe and life-threatening adverse events in the Yondelis treatment group, including more than twice as many incidents of pulmonary embolism. Cardiac adverse events were three times higher in the trabectedin group, and liver enzyme increases were also higher.

Some panellists said that they would be willing to look at Yondelis again once overall survival data is known, though that could take up to two years. J&J’s Centocor Ortho Biotech unit said that it continues to believe 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”.

The company noted that ovarian cancer is difficult to treat and often recurs in patients who previously have been treated with platinum-based therapy, “underscoring the need for non-platinum treatment options”. JP Morgan analyst Michael Weinstein issued a research note saying that the impact on earnings for the US healthcare giant, saying that “expectations for Yondelis were low, and this was by no means one of the higher profile programs in J&J's pipeline, but it is a negative nonetheless".

The drug is far more important for Zeltia and its shares have sunk. The ODAC’s recommendations come a week after the Madrid-headquartered firm was boosted by regulators in the Philippines approving Yondelis for recurrent ovarian cancer as well as advanced soft tissue sarcoma. The drug is already available for the latter indication in Europe and a number of other territories, including Argentina, Venezuela, South Korea and Russia.