US FDA accepts Spectrum Pharmaceuticals’ poziotinib NDA for review
The acceptance by the FDA is based on the positive data from a Phase II study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
The US Food and Drug Administration (FDA) has approved an expanded indication for Eli Lilly and Company’s Jaypirca (pirtobrutinib) as a first-line treatment for adults with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a 17p deletion.