Xalkori

Xalkori (crizotinib) is indicated for the treatment of previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The Marketing Authorisation Application was submitted on 28 July 2011, and a positive opinion for Conditional Marketing Authorisation was issued on 19 July 2012.

In a Phase 2, single-arm, open-label trial, Xalkori demonstrated an Objective Response Rate (ORR) of 61.2% (95% CI: 51.7%, 70.1%) and a median Progression-Free Survival (mPFS) of 10.0 months (95% CI: 8.2 months, 14.7 months). The 1-year survival probability was 80.5%. For comparison, platinum-based chemotherapy showed an ORR of 15% to 32%, mPFS of 3-6 months, and 1-year OS of 34% to 44%. Single-agent chemotherapy (second-line) had an approximate ORR of 9%, mPFS of approximately 3 months, and 1-year OS of 30%. Pemetrexed (non-squamous) had an ORR of 11.5% and mPFS of 3.1 months.

Safety findings include 96.6% of patients experiencing at least one treatment-related adverse event (AE), with 38.9% experiencing serious AEs (SAEs). Grade 3-4 AEs occurred in 51.7% of patients, and AEs leading to discontinuation occurred in 12.8%. QTc prolongation was observed, with 1.0% of patients experiencing QTcF >= 500 msec and 4.1% experiencing an increase from baseline QTcF >= 60 msec.