AP News

Pfizer cancer pill gets EU OK as second treatment

TRENTON, N.J. (AP) — Drugmaker Pfizer Inc. said Tuesday that European regulators have approved the sale of its new medicine for a type of advanced kidney cancer.

The European Commission approved the use of Inlyta in adult patients with renal cell carcinoma who have already been treated unsuccessfully with certain other kidney cancer drugs.

Inlyta, known chemically as axitinib, is a pill that's part of a promising new generation of targeted cancer drugs from Pfizer. It targets proteins that affect the growth and spread of tumors and the development of new blood vessels to feed those tumors.

A large study sponsored by New York-based Pfizer found the drug extended the time until patients' cancer progressed to a median of 6.8 months, from 4.7 months in patients taking a standard kidney cancer drug.

Renal cell carcinoma is the sixth-leading cause of cancer deaths. About a third of patients are not diagnosed until the cancer has spread to multiple body parts, limiting chances of survival. Roughly half of patients worldwide whose cancer worsens after initial therapy are then given a second treatment, and Inlyta will now be a possible option for them.

It's one of three drugs for advanced renal cell carcinoma made by Pfizer, the world's largest drugmaker. The others are Sutent and Torisel.

Inlyta was approved for use in the U.S. in January and has been approved in several other countries, including Japan, Canada, Australia, Switzerland and South Korea.

Common side effects from taking Inlyta include diarrhea, nausea, decreased appetite, fatigue, high blood pressure and difficulty speaking. Less-common but more-serious reactions in patients taking the medicine include dangerous clots in arteries and veins, internal bleeding, development of perforations or abnormal connections within the gastrointestinal tract, and severe blood pressure spikes that can trigger a stroke.

Pfizer's stock fell 6 cents to $23.80 in morning trading.

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