EU gives Pfizer cancer drug conditional approval
NEW YORK (AP) — Drug giant Pfizer Inc. said Wednesday that it's received conditional approval to market its lung cancer pill Xalkori for certain patients in the European Union.
The drug, also known by the chemical name crizotinib, is for adults who have failed prior treatment for advanced non-small cell lung cancer and have a genetic mutation found in less than 7 percent of patients with that cancer. It can shrink tumors and delay progression of the cancer.
The European Commission grants conditional marketing authorizations, which are renewable annually, for medicines that address unmet medical need and offer patients more benefit than risk. The company said it will be required to submit data from a recently completed study of Xalkori to the European Medicines Agency. The European Commission will then decide whether to grant full marketing approval.
The drug already is approved in the U.S., Japan, Canada and other countries.
Xalkori has significant possible side effects, including liver damage and an irregular heartbeat, both of which can be fatal. Other side effects include damage to peripheral nerves, a drop in infection-fighting white blood cells, harm to a fetus in pregnant women, vision disorder, nausea, diarrhea, vomiting, swelling in the legs or other body parts, constipation and fatigue.
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