US FDA agrees to speed up Xalkori review in two new indications

30 May 2018

The US regulator has granted New York’s Pfizer (NYSE: PFE) two Breakthrough Therapy designations for Xalkori (crizotinib), a tyrosine kinase inhibitor (TKI) with widespread approval against lung cancer.

Pfizer wants to expand the label for Xalkori to include a new biomarker-defined patient population in non-small cell lung cancer, as a second-line treatment.

The firm is also trialling the drug as a treatment for certain patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).

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