FDA staff question benefit of Merck-Ariad drug

WASHINGTON (Reuters) - U.S. drug reviewers questioned whether a sarcoma treatment from Merck & Co Inc and Ariad Pharmaceuticals Inc kept tumors at bay for long enough, given the drug's serious side effects.

The drug, called Taltorvic, is meant as a maintenance therapy for people with soft tissue or bone sarcoma who have had four successful rounds of chemotherapy.

U.S. Food and Drug Administration staff found the drug stopped cancer from spreading two weeks longer than a placebo, according to FDA documents posted online on Friday. But the drug had serious safety issues, such as kidney failure, infection and inflamed lung tissue, the documents said.

About 14 percent of patients discontinued treatment because of side effects, compared with 2 percent of patients who stopped taking the placebo.

"The number of patients who discontinued due to an adverse event is of particular concern in a drug intended for use as maintenance therapy," the FDA staff said in the documents.

Maintenance therapies help people stay disease-free once their cancer is in remission. There are currently no FDA-approved maintenance therapies for sarcoma.

A panel of outside experts to the FDA will vote on whether to recommend approval of Taltorvic on Tuesday, and the FDA will later make the final decision.

Ariad shares fell 4 percent to $14.83 on Nasdaq, compared with a slight rise in the Arca pharmaceuticals index. Shares of the bigger Merck were up 0.4 percent at $38.20 on the New York Stock Exchange.

Cory Kasimov, an analyst at J.P. Morgan, said the documents were not a big surprise, as other drugs in the same class as Taltorvic have similar safety issues.

"We ... believe Tuesday's panel will come down to whether the panel sees the unmet medical need overcoming Taltorvic's modest absolute benefit and (adverse event) profile," Kasimov said in a research note.

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FDA staff question benefit of Merck-Ariad drug