The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
New top-line data from Kintara Therapeutics Inc.’s phase II study of its lead candidate, VAL-083, in recurrent glioblastoma multiforme were incrementally better than data released in April, and that’s just fine with CEO Saiid Zarrabian. “Normally, in my experience, top-line data usually regresses a little,” Zarrabian told BioWorld. “The fact that it improved could be a reflection of the small size of the study, but it adds a little more interest to top-line data.”
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