NEW YORK (AP) – Pfizer Inc. said that a European Union advisory panel recommended that its lung cancer drug Xalkori get conditional marketing approval.
The panel recommended that Xalkori be approved conditionally for use in patients who have already received at least one treatment for lung cancer. The non-binding opinion will be considered by EU regulators. Pfizer said that if Xalkori gets conditional approval, it will be required to submit data from a recently completed clinical trial. Regulators could give the drug full approval after reviewing those results.
Drugs that address unmet medical needs sometimes get conditional approvals so patients can use the products before they get full marketing approval. Xalkori targets cancer linked to a genetic mutation found in less than 7% of non-small cell lung cancer patients.
The U.S. Food and Drug Administration approved Xalkori, or crizotinib, in August as a treatment for non-small cell lung cancer that has advanced locally or spread to other parts of the body. The drug is also approved in Japan, Canada and other countries.
Date: July 20, 2012
Source: Associated Press
Filed Under: Drug Discovery
