Bristol Myers Squibb (BMS, NYSE: BMY), a leading U.S. pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Abraxane (paclitaxel, albumin). This approval is for the first-line treatment of metastatic pancreatic cancer in combination with gemcitabine.
Since June 2008, Abraxane has garnered approval for indications in lung cancer, breast cancer, and other conditions. The latest approval is supported by multiple large-scale clinical studies, including the MPACT study, a global Phase III randomized controlled trial that enrolled 861 patients. This study demonstrated that the Abraxane combination significantly extended overall survival (mOS: 8.5 months vs 6.7 months), progression-free survival (mPFS: 5.5 months vs 3.7 months), and the objective response rate (ORR: 23% vs 7%) for patients. Additionally, the multi-center Phase II PANC-001 study conducted in China showed a 35% objective response rate with the combination therapy. Both studies reported good overall tolerability, with no new safety signals detected.- Flcube.com
