PDF of News 1212


The FDA has approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane for Injectable Suspension) for use in combination with carboplatin for the initial treatment of persons with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for curative surgery or radiation therapy. 



A 90-minute infusion of rituximab (Rituxan Injection) starting at cycle 2 received FDA approval for patients with non-Hodgkin lymphoma who did not experience a grade 3 or grade 4 infusion-related adverse reaction during cycle 1. This faster infusion is not recommended for patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (5,000/µL or higher).


Omacetaxine mepesuccinate (Synribo) received FDA approval for the treatment of chronic-phase or accelerated-phase chronic myeloid leukemia (CML) in adults who are resistant to or intolerant of two or more tyrosine kinase inhibitors. Accelerated approval was granted after two studies showed that the agent reduced the percentage of cells expressing the Philadelphia chromosome genetic mutation found in most people with CML. ONA