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Pfizer's cancer drug Xalkori bags US FDA breakthrough status in 2 new uses

The U.S. Food and Drug Administration granted breakthrough therapy designation to Pfizer Inc.'s Xalkori medicine in two additional uses.

The New York- based pharmaceutical giant said the first breakthrough status was granted to Xalkori, which is also known as crizotinib, to treat patients whose non-small cell lung cancer had the MET exon 14 gene alteration.

Pfizer said the breakthrough designation was based on data from a phase 1 study, known as Profile 1001, in which the medicine showed anti-tumor activity.

The company said the second breakthrough therapy designation was granted to Xalkori to treat patients with a rare type of blood cancer known as anaplastic large cell lymphoma who are also anaplastic lymphoma kinase, or ALK-positive, signifying an abnormality in a gene that can occur in cancer cells.

Pfizer said the breakthrough designation for this particular use was based on data from two studies that showed "compelling anti-tumor activity" in children and adult patients.

Xalkori is approved in the U.S. for treating patients whose non-small cell lung cancer has spread to other parts and whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test.

The U.S. FDA's breakthrough therapy designation is intended to expedite the development and review of a medicine to treat a serious or life-threatening disease.