PharmaMar’s cancer drug Yondelis could be approved in the US within a few months after it was fast-tracked by the FDA as a therapy for advanced soft-tissue sarcoma (STS).
Yondelis (trabectedin) – which will be sold by Johnson & Johnson’s Janssen unit in the US – is already approved in more than 70 countries worldwide as a monotherapy to treat this type of cancer, as well as for ovarian cancer in combination with pegylated liposomal doxorubicin.
The FDA will review the application to market Yondelis as a treatment for STS, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline, within six rather than the usual 10 months.
It is a major development for Yondelis, which was turned down by the FDA in 2009 after questions were raised about the interpretation of imaging data in an ovarian cancer trial.
Yondelis was also due to be filed for approval in Japan by licensee Taiho before the end of 2014 and – according to analysts at Edison – approval in both the new markets would be “financially transformative” for PharmaMar’s parent company Zeltia.
Approval in the US and Japan would provide a significant increase in sales of the drug, which were a little under €60m in the first nine months of 2014 and were made mainly in Europe.
“In these markets Yondelis is likely to be priced at a premium to Europe and royalty receipts should significantly boost revenues and profitability,” said the analysts in a recent research note, adding that US approval could also “have positive knock-on effects on European sales in STS.”
“We are particularly proud of this filing, as it represents our commitment to Yondelis and the people it may help,” said Janssen’s global oncology head Peter Lebowitz.
“The advanced STS treatment landscape has been relatively stagnant for decades and it’s our hope that Yondelis will be a new treatment option for people living with this aggressive disease,” he added.
More than 12,000 people in the US are diagnosed with STS each year, and approximately 4,700 die as a result of the disease.