AP News

J&J gets new European approvals for cancer drugs


NEW YORK (AP) — Johnson & Johnson said Friday that European Union regulators awarded marketing approvals to two of its cancer treatments.

The company's Janssen Cilag business said Dacogen is now approved as a treatment for acute myeloid leukemia in elderly people who are not candidates for standard chemotherapy.

Dacogen has orphan drug status as a treatment for acute myeloid leukemia, an aggressive cancer of the blood. The status means similar drugs won't be approved for up to 10 years.

The drug is already approved as a treatment for myelodysplastic syndromes, a group of blood cancers. The new approval allows Janssen to market it for AML patients 65 years and older who have newly diagnosed or secondary disease.

Astex Pharmaceuticals Inc. developed Dacogen and licensed it to Japanese drugmaker Eisai, which has the right to market Dacogen in North America. Johnson & Johnson holds the rights in all other markets as the result of a deal with Eisai. Astex said it receives royalty payments of at least 20 percent on all worldwide sales of Dacogen, and it could get another $17.5 million in milestone payments based on sales of the drug.

The European Commission also approved an injectable version of Velcade, a drug that was previously approved in IV form. Velcade is a treatment for multiple myeloma, a bone marrow cancer.

Shares of New Brunswick, N.J.-based Johnson & Johnson shares declined 4 cents to $68.97 in afternoon trading. Astex shares gained 4 cents to $3.14.


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