Ariad Pharmaceuticals Inc. (ARIA) has secured marketing approval and label expansion from the U.S. Food And Drug Administration (FDA) for its leukemia drug, Iclusig (ponatinib).

Iclusig is used to treat adult patients with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Iclusig was first approved in December 2012 under the FDA’s accelerated approval program to treat two rare types of leukemia disorders. The recent FDA clearance expands the drug's use.

Good Study Results

The latest agency approval was based on the results from Phase 2 clinical trial involving 449 patients with resistant or intolerant CML or Ph+ ALL who had previously been treated with two or more approved therapies.

The patients were treated with ponatinib at a starting dose of 45 mg/day. After 48 months, follow-up reports showed that the patients retained long-term cytogenetic and molecular responses, indicating improvements in their condition.

Promising Sales Numbers 

Chronic myeloid leukemia (CML) is a type of cancer that affects the blood and bone marrow. It occurs when the bone marrow produces a high number of white cells called granulocytes, which lead to gradual congestion of the bone marrow and interference with normal blood cell production.

Iclusig works by targeting the compounds which are resistant to treatment.

The drug is now approved in the US, EU, Australia, Switzerland, Israel, Canada and Japan. It secured approval in Japan in late September for certain CML indications. (For more, see Ariad Hits 52-Week High on Japan Approval.)

While Ariad has been under fire for continued price increases of Iclusig, the company reported healthy sales during recently finished third quarter. (For more, see Ariad Continues Iclusig Price Hike.)

Third-quarter U.S. drug sales topped $33.6 million, up 66% over Q3 2015, while global sales stood at $34.3 million in the third quarter, up 25% year over year. (For more, see Ariad Pharma 3Q Loss 14c/Share Beats Street.)

The recent label expansion will bolster Iclusig sales. During Q3, Ariad Pharmaceuticals had estimated Iclusig sales and royalty revenues at $170 million to $180 million. (For more, see Ariad Receives Interest as a Buyout Candidate.)

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