29 May 2018 - Xalkori is the first tyrosine kinase inhibitor to receive breakthrough designation for the treatment of patients with previously-treated metastatic non-small cell lung cancer with MET exon 14 alterations.

Pfizer announced today that the U.S. FDA granted breakthrough therapy designation for Xalkori (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The FDA also granted breakthrough therapy designation for Xalkori for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.

The breakthrough therapy designation for patients with metastatic NSCLC with MET exon 14 alterations was supported by results from an expansion cohort of the Phase 1 PROFILE 1001 study, in which Xalkori showed anti-tumour activity.

The designation for patients with relapsed or refractory systemic ALCL that is ALK-positive was supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). Study ADVL0912 is a Phase 1/2 study conducted by the Children’s Oncology Group evaluating the maximum dose that is safe and tolerable, and assessing preliminary clinical activity in pediatric patients with relapsed or refractory solid tumors and ALCL. Study A8081013 evaluated XALKORI in pediatric and adult patients with advanced malignancies known to be ALK-positive other than NSCLC and included patients with relapsed/refractory ALCL. These two studies showed compelling antitumor activity in pediatric and adult patients who received XALKORI.

Read Pfizer press release