October 23, 2015 / 3:06 PM / 4 years ago

FDA clears J&J's chemotherapy for certain soft tissue sarcomas

(Reuters) - The U.S. Food and Drug Administration said it approved Johnson & Johnson’s chemotherapy to treat specific soft-tissue sarcomas (STS) that have spread to other parts of the body or cannot be removed by surgery.

A first aid kit made by Johnson & Johnson for sale on a store shelf in Westminster, Colorado April 14, 2009. J REUTERS/Rick Wilking

The drug, Yondelis, is designed to delay the progression of cancer that occurs in fat cells called liposarcoma (LPS) or smooth muscle cells called leiomyosarcoma (LMS) - two rare and aggressive forms of cancer with limited treatment options.

J&J said that while the FDA approved Yondelis to treat both LPS and LMS, which account for about 35 percent of all STS cases, the drug is the first treatment to be specifically approved for LPS in the United States.

Data showed Yondelis delayed the growth of a tumor by about 4.2 months on average. In contrast, dacarbazine, another form of chemotherapy, delayed the progression by an average of 1.5 months after initiating therapy.

Yondelis, which won European approval in 2007, is FDA-approved for use in patients who have previously received treatment containing the chemotherapeutic agent anthracycline. (1.usa.gov/203yH73)

The drug is derived originally from the sea squirt, Ecteinascidia turbinata, and is administered every three weeks via an infusion.

A vial of Yondelis will cost about $2,700 in the United States, with the average patient needing three vials per infusion, J&J spokeswoman Bernadette King told Reuters.

King said clinical data showed a patient typically needs about four to five infusions, meaning a course of therapy would cost no more than $40,500.

About 12,000 cases of soft-tissue sarcoma were diagnosed in the United States last year, the FDA said.

J&J said it expects the drug will be available from the week of Nov. 16.

Reporting by Natalie Grover in Bengaluru; Editing by Don Sebastian and Savio D'Souza

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