Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration or FDA has accepted the company's New Drug Application or NDA and granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase or ALK inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer or NSCLC who have progressed on or are intolerant to crizotinib.
Alectinib was granted Breakthrough Therapy Designation by the FDA in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib...
"Solid revenue growth underscores the fundamental strengths of our businesses... However, our challenges are also evident in the unacceptably high level of our costs, our continuing burden of heavy litigation charges, a balance sheet that must be more efficient, and the poor overall returns to our shareholders," said the bank's new co-Chief Executive John Cryan, who replaced Anshu Jain on July 1. Fellow co-CEO Jürgen Fitschen is due to leave his post next May.
Germany's biggest lender said net profit more than tripled to EUR796 million ($873.52 million) from EUR237 million in the same period last year, on revenue of EUR9.2 billion, up from EUR7.86 billion. Its tax rate fell to 33% from 74% a year earlier.