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FDA Breakthrough Therapy Designation: Another For Genentech And Cancer

May 31, 2014

On May 31st, 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 50th 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 common cancer worldwide

•   No new treatments in nearly 30 years

•   In the US, > 74,000 will be diagnosed with bladder cancer in 2014; About 15,000 of new diagnosed cases are made when in advanced stages.

This is the 42nd BTD announced by a sponsor company, the 2nd BTD for Genentech, and the 1st BTD for Bladder Cancer:

Num Drug Name Indication
1 Obinutuzumab





2 MPDL3280A (anti-PDL1) Urothelial Bladder Cancer (UBC)




FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.


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