IQWiG rebuffs Pfizer's Xalkori

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said in a preliminary benefit assessment that Xalkori crizotinib from Pfizer Inc. (NYSE:PFE) provides "no additional benefit" over docetaxel or pemetrexed-containing chemotherapy in patients with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase ( ALK)-positive -- Xalkori's approved indication. IQWiG said Xalkori may lead to improvements in health-related quality of life vs. the comparators requested by Germany's Federal Joint Committee (G-BA) in patients for whom chemotherapy is still an option. However, IQWIG said patients receiving Xalkori were at an increased risk for serious adverse events.

Because Pfizer's dossier did not include the requested data, IQWiG said Xalkori also has "no additional benefit" over G-BA's requested comparator of best supportive care (BSC) in patients for whom chemotherapy is no longer an option. Pfizer said it disagrees with the assessment and will respond before the March 8 deadline. A final assessment from G-BA is expected in early May. ...