Roche Holding AG (RHHBY - Analyst Report) announced that the FDA has approved its lung cancer drug, Alecensa, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer Inc.’s (PFE - Analyst Report) Xalkori (crizotinib).
Alecensa gained an accelerated approval from the FDA based on its tumor response rate and duration of response. Data from the pivotal studies suggested that Alecensa was able to shrink tumors in up to 44% of patients with ALK-positive NSCLC who had progressed on Xalkori.
