Johnson & Johnson unit voluntarily withdraws NDA for trabectedin

Centocor Ortho Biotech Products, a division of US health care giant Johnson & Johnson (NYSE: JNJ), says it has voluntarily withdrawn the New Drug Application for trabectedin for the treatment of women with recurrent ovarian cancer (ROC). The withdrawal is based on the US Food and Drug Administration's recommendation that an additional Phase III study be conducted to obtain approval.

Under a licensing agreement with PharmaMar, a subsidiary of Spain’s Zeltia (ZEL: MC), Centocor Ortho Biotech has worldwide marketing rights for trabectedin except in Europe, where the product is marketed by PharmaMar and in Japan, by Taiho Pharmaceutical. In countries where it has received marketing authorization, trabectedin is marketed as Yondelis.

As a result of J&J’s decision, the Spanish group will miss out on a $10 million milestone which would have been due on US approval of the drug, according to a report by Bloomberg. Last week, Yondelis, which generated sales of 43.8 million euros ($63.8 million) for Zeltia last year, received a final refusal for use in the UK’s National Health Service (The Pharma Letter April 27). Also, Australia's Advisory Committee on Prescription Medicines (APCM) decided last November not to recommend Yondelis for soft tissue sarcoma and ovarian cancer.