Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
announced that it has received a second Breakthrough Therapy
Designation from the U.S. Food and Drug Administration (FDA) for its
investigational cancer immunotherapy MPDL3280A (anti-PDL1).
"Lung cancer is the leading cause of cancer death globally, and we are
pleased the FDA has granted breakthrough designation for MPDL3280A in
non-small cell lung cancer," said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. "We are committed to
personalized healthcare, developing medicines like MPDL3280A with
companion tests that may help us identify those who may be appropriate
candidates for our medicines."
Breakthrough Therapy Designation is designed to expedite the development
and review of medicines intended to treat serious diseases and to help
ensure patients have access to them through FDA approval as soon as
possible.
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