MADRID, April 29 (Reuters) - Spanish drug company Zeltia ZEL.MC said on Friday U.S. group Johnson & Johnson (JNJ.N) had withdrawn its petition to the Federal Drug Administration to authorise the use of Yondelis in combination with Doxil.
The Spanish group said J&J had dropped its request to combine Yondelis, a drug made by Zeltia affiliate Pharma Mar, with J&J’s Doxil for the treatment of ovarian cancer in remission after the FDA had recommended an additional test phase before approval.
Zeltia said the decision, taken by J&J’s affiliate Centocar Ortho Biotech Products, would not stop the future presentation of a new drug, including additional test data, to the American Society of Clinical Oncologists (ASCO) June 5.
The announcement could be taken as a further setback for Zeltia after Australia’s APCM decided in November not to recommend Yondelis for soft tissue sarcoma and ovarian cancer.
According to a report, the health risks posed by the drug outweigh its potential effectiveness. (Reporting by Paul Day, editing by Matthew Lewis)