J&J's cancer drug finally wins FDA approval after 6 years of delay

About 6 years after its first rejection, Johnson & Johnson's ($JNJ) long-delayed cancer drug Yondelis won FDA approval to treat soft tissue sarcomas, finding success in its third go round.

The drug is approved to treat two specific cancers of the connective tissue, liposarcoma and leiomyosarcoma, that have endured standard chemotherapy and cannot be surgically removed, the FDA said. The nod is based on a Phase III trial involving 518 sarcoma sufferers in which Yondelis significantly improved progression-free survival compared with the old chemo drug dacarbazine.

For J&J, the approval is a bright conclusion to a long R&D journey. The company licensed Yondelis from Spanish drugmaker Zeltia back in 2001, working to develop it as a treatment for ovarian cancer. That effort blew up in 2009 when the FDA rejected a combination of Yondelis and J&J's Doxil over safety concerns and subpar efficacy. Two years later, J&J aborted a comeback effort in the same indication, later turning its focus to sarcoma.

The drug is already on the market around the world through Zeltia and its various partners, while J&J holds exclusive U.S. rights.

Soft tissue sarcomas kill nearly 5,000 people each year, according to J&J. Leiomyosarcoma is a particularly aggressive form of the disease, affecting smooth muscles, while liposarcoma originates in fat cells.

- read the statement

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