LONDON (Reuters) - European Union regulators have recommended Pfizer’s new genetically targeted lung cancer drug Xalkori for approval, following marketing approval for the medicine in the United States last August.
The U.S. drugmaker said on Friday the European Medicines Agency had recommended the medicine for conditional authorization, which means Pfizer will need to submit further data from a recent successfully completed clinical trial.
Recommendations for drug approvals by the EMA are normally formally endorsed by the European Commission within months.
The green light consolidated the position of Pfizer’s new cancer medicine, expected to achieve annual sales of $1.5 billion by 2017, according to consensus forecasts compiled by Thomson Reuters Pharma.
Xalkori, or crizotinib, targets a small subset of patients with advanced non-small cell lung cancer with a specific genetic mutation. It was designed for use with a companion diagnostic test that identifies which patients will benefit from the treatment.
The oral medicine treats patients who express an abnormal anaplastic lymphoma kinase (ALK) gene, which is more common in nonsmokers.
About 4 percent of lung cancer patients tend to be ALK positive, but about 10-15 percent of lung cancer patients who were never smokers fall into the category.
Reporting by Ben Hirschler; Editing by Dan Lalor