FDA Breakthrough Therapy Designation: Another For Genentech And Cancer

On May 31^st, Genentech (member of the Roche Group) strategically announces that the FDA grants the Breakthrough Therapy Designation (BTD) to the company’s investigational cancer immunotherapy MPDL3280A (anti-PDL1) for the treatment of Bladder Cancer. At the 50^th Annual Meeting of the American Society of Clinical Oncology (ASCO), now in progress in Chicago, Dr. Thomas Powles, M.D., clinical Professor of Genitourinary Oncology, Barts Cancer Institute at the Queen Mary University of London, is presenting on May 31st, Abstract #5011 (Results of the Phase I MPDL3280A Study).

The Phase I MPDL3280A Study, a single-arm, multi-center, open label trial, shows that MPDL3280A “shrank tumors (ORR – Overall Response Rate) in 43% (13/30) of people previously treated for metastatic Urothelial Bladder Cancer (UBC), whose tumors were characterized as PD-L1 (Programmed Death Ligand-1) positive by a test being developed by Roche.”

Per the Genentech Press Release, bladder cancer:

•   Is the 9th most…