It is approved for use in Europe, Russia and South Korea for the treatment of advanced soft tissue sarcoma. It is also undergoing clinical trials for the treatment of breast, prostate, and paediatric sarcomas. The European Commission and the U.S. FDA have granted orphan drug status to trabectedin for soft tissue sarcomas and ovarian cancer.
On July 15, a panel of cancer experts recommended the FDA not approve the use of Yondelis, saying risks of heart and liver toxicity outweighed its limited ability to keep the disease in check.
In a regulatory filing, Zeltia said the FDA had contacted J&J unit Centocor Ortho Biotech Products.
"The agency has requested additional information, including overall survival data from the company's ongoing pivotal trial and additional clinical pharmacology studies," a Centocor statement included in the filing said.
In a preliminary review released ahead of the meeting, FDA said it was considering whether to wait for more data on survival rates before making a decision on the drug, according to Forbes' report.