FDA Grants Genentech’s Trastuzumab Emtansine (T-DM1) Priority Review for HER2-positive Metastatic Breast Cancer

  FDA Grants Genentech’s Trastuzumab Emtansine (T-DM1) Priority Review for
  HER2-positive Metastatic Breast Cancer

Business Wire

SOUTH SAN FRANCISCO, Calif. -- November 06, 2012

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced that the U.S. Food and Drug Administration (FDA) has accepted the
company's Biologics License Application (BLA) for trastuzumab emtansine
(T-DM1) and granted Priority Review. Trastuzumab emtansine’s proposed
indication is for the treatment of people with HER2-positive, unresectable
locally advanced or metastatic breast cancer (mBC) who have received prior
treatment with Herceptin® (trastuzumab) ^ and a taxane chemotherapy. The FDA
confirmed the action date is February 26, 2013.

“We are very pleased that the FDA has grantedtrastuzumab emtansinea Priority
Review, as we know people with HER2-positive metastatic breast cancerstill
neednewtreatment options,”said Hal Barron, M.D., chief medical officer and
head, Global Product Development.

Roche’s Marketing Authorization Application for trastuzumab emtansine for
people with HER2-positive mBC has also been accepted for review by the
European Medicines Agency (EMA).

About Trastuzumab Emtansine

Trastuzumab emtansine is an antibody-drug conjugate (ADC) being studied in
HER2-positive cancers. It is comprised of the antibody trastuzumab and the
chemotherapy DM1 attached together using a stable linker. Trastuzumab
emtansine is designed to target and inhibit HER2 signaling and deliver the
chemotherapy DM1 directly inside HER2-positive cancer cells. Trastuzumab
emtansine binds to HER2-positive cancer cells and is thought to block
out-of-control signals that make the cancer grow while also calling on the
body's immune system to attack the cancer cells. Once trastuzumab emtansine is
taken up by those cancer cells, it is designed to destroy them by releasing
the DM1.

Genentech licenses technology for trastuzumab emtansine under an agreement
with ImmunoGen, Inc.

Building on the results of trastuzumab emtansine studies to date, there are
approximately 25 ADCs in Genentech and Roche’s pipeline.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. According to
the American Cancer Society, approximately 229,000 people will be diagnosed
with breast cancer, and 40,000 will die from the disease in 2012. In
HER2-positive breast cancer, increased quantities of the Human Epidermal
growth factor Receptor 2 (HER2) are present on the surface of the tumor cells.
This is known as “HER2 positivity” and affects approximately 25 percent of
people with breast cancer. HER2-positive cancer is a particularly aggressive
form of breast cancer.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company
that discovers, develops, manufactures and commercializes medicines to treat
patients with serious or life-threatening medical conditions. The company, a
member of the Roche Group, has headquarters in South San Francisco,
California. For additional information about the company, please visit


Media Contact:
Susan Willson, 650-467-6800
Advocacy Contact:
Sonali Padhi, 650-467-0842
Investor Contacts:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
Press spacebar to pause and continue. Press esc to stop.