FDA Approves Genentech’s Kadcyla (Ado-Trastuzumab Emtansine), the First Antibody-Drug Conjugate for Treating HER2-Positive

  FDA Approves Genentech’s Kadcyla (Ado-Trastuzumab Emtansine), the First
  Antibody-Drug Conjugate for Treating HER2-Positive Metastatic Breast Cancer

  -- New Personalized Medicine Helped People in Phase III Study Live Longer,
                      Compared to Standard Treatment --

Business Wire

SOUTH SAN FRANCISCO, Calif. -- February 22, 2013

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced that the U.S. Food and Drug Administration (FDA) has approved
Kadcyla™ ^ (ado-trastuzumab emtansine or T-DM1) for the treatment of people
with HER2-positive metastatic breast cancer (mBC) who have received prior
treatment with Herceptin^® (trastuzumab) and a taxane chemotherapy. Kadcyla is
the fourth medicine from Genentech to receive FDA approval for people with
advanced cancers within the past two years.

An antibody-drug conjugate (ADC) is a new kind of targeted cancer medicine
that can attach to certain types of cancer cells and deliver chemotherapy
directly to them.Kadcyla is the first FDA-approved ADC for treating
HER2-positive mBC, an aggressive form of the disease.

“Kadcyla is an antibody-drug conjugate representing a completely new way to
treat HER2-positive metastatic breast cancer, andit helped people in the
EMILIA study live nearly six months longer,” said Hal Barron, M.D., chief
medical officer and head, Global Product Development. “We currently have more
than 25 antibody-drug conjugates in our pipeline and hope this promising
approach will help us deliver more medicines to fight other cancers in the

Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1,
joined together using a stable linker. Kadcyla combines the mechanisms of
action of both trastuzumab and DM1, and it is the first Genentech ADC approved
by the FDA. Genentech has studied ADC science for more than a decade and has
eight ADCs in Phase I or Phase II studies for different types of cancer.

Kadcyla will be available to people in the United States within two weeks. As
part of this approval, Genentech plans to initiate patient assistance programs
for people taking Kadcyla through Genentech Access Solutions. These programs
help people who might not be able to afford this medicine. People who do not
have health insurance, or who have reached the lifetime limit set by their
insurance company, might qualify to receive Kadcyla free of charge. For people
with insurance, Genentech Access Solutions offers co-pay assistance programs
to help with the out-of-pocket costs of their medicine, including a co-pay
card for those with private insurance. The card pays 80 percent of
out-of-pocket costs for people who qualify (up to $9,000 or $24,000 per year,
depending on the person’s income).

Doctors can contact Genentech Access Solutions at (888) 249-4918. More
information is also available at http://www.Genentech-Access.com.

Roche has also submitted a Marketing Authorization Application to other
regulatory authorities around the world, including the European Medicines
Agency (EMA), for Kadcyla for the treatment of people with HER2-positive mBC.
This application is currently under review by the EMA.

Kadcyla Efficacy in HER2-positive mBC

The FDA approval of Kadcyla is based on results from EMILIA
(TDM4370g/BO21977), an international, Phase III, randomized, open-label study
comparing Kadcyla alone to lapatinib in combination with Xeloda^®
(capecitabine) in 991 people with HER2-positive locally advanced breast cancer
or mBC who had previously been treated with Herceptin and a taxane
chemotherapy. Results include:

  *The study met both co-primary efficacy endpoints of overall survival and
    progression-free survival (PFS; as assessed by an independent review
  *People who received Kadcyla lived a median of 5.8 months longer (overall
    survival) than those who received the combination of lapatinib and Xeloda,
    the standard of care in this setting (median overall survival: 30.9 months
    vs. 25.1 months).
  *People receiving Kadcyla experienced a 32 percent reduction in the risk of
    dying compared to people who received lapatinib and Xeloda (HR=0.68;
  *People who received Kadcyla lived significantly longer without their
    disease getting worse (PFS) compared to those who received lapatinib plus
    Xeloda (HR=0.65, 35 percent reduction in risk of disease worsening or
    death, p<0.0001; median PFS 9.6 months vs. 6.4 months).
  *No new safety signals were observed and adverse events (AEs) were
    consistent with those seen in previous studies, with fewer people who
    received Kadcyla experiencing Grade 3 or higher (severe) AEs than those
    who received lapatinib plus Xeloda (43.1 percent vs. 59.2 percent).
  *For people receiving Kadcyla, the most common (occurring in more than 2
    percent of participants) Grade 3 or higher AEs were low platelet count
    (14.5 percent), increased levels of enzymes released by the liver and
    other organs (8.0 percent), low red blood cell count (4.1 percent), low
    levels of potassium in the blood (2.7 percent), nerve problems (2.2
    percent) and tiredness (2.5 percent).

About Kadcyla (pronounced kad SIGH luh); ado-trastuzumab emtansine (pronounced
ADD oh traz TOO zuh mab em TAN zine)

Kadcyla is an ADC being studied in HER2-positive cancers. It is the first ADC
to result from Genentech’s 30 years of HER2 pathway research and the third
medicine Genentech has developed for the treatment of HER2-positive breast

Like Herceptin, Kadcyla binds to HER2-positive 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 Kadcyla is taken up by
those cells, it is designed to destroy them by releasing the DM1 inside the

Genentech licenses technology for Kadcyla under an agreement with ImmunoGen,

Kadcyla Indication Statement

Kadcyla™ (ado-trastuzumab emtansine) is approved as a single medicine for the
treatment of people with HER2-positive metastatic breast cancer (mBC) who have
received prior treatment with Herceptin^®(trastuzumab) and a taxane
chemotherapy. People should either:

  *Have already been treated for their metastatic cancer, or
  *Have had their early-stage cancer come back during or within six
    monthsafter they completed a course of treatment following surgery.

Important Safety Information

Kadcyla is not the same medicine as Herceptin.

There are possible serious side effects of Kadcyla. Patients must contact
their doctor right away if they experience any of these symptoms. The
patient’s doctor may do tests before starting Kadcyla and before each dose to
monitor for these side effects. Kadcyla treatment may be stopped or the dose
may be lowered if the patient experiences any of these side effects.

Liver Problems

  *Kadcyla may cause severe liver problems that can be life-threatening.
    Symptoms of liver problems may include vomiting, nausea, stomach pain,
    dark urine or itching.

Heart Problems

  *Kadcyla may cause heart problems, including those without symptoms (such
    as reduced heart function) and those with symptoms (such as congestive
    heart failure). Symptoms may include swelling of the ankles or legs,
    shortness of breath, cough or rapid weight gain of greater than five
    pounds in less than 24 hours.


  *Receiving Kadcyla during pregnancy can result in the death of an unborn
    baby and birth defects. Birth control should be used while patients
    receive Kadcyla and for six months after their last dose of Kadcyla.
  *If patients are exposed to Kadcyla during pregnancy, they must contact
    their healthcare provider right away; they are also encouraged to enroll
    in the MotHER Pregnancy Registry by contacting (800) 690-6720.
  *If patients are mothers who are breastfeeding, they should talk with their
    doctor about either stopping breastfeeding or stopping treatment with

Additional Possible Serious Side Effects of Kadcyla

Lung Problems

  *Kadcyla may cause lung problems, including inflammation of the lung
    tissue, which can be life-threatening. Signs of lung problems may include
    trouble breathing, cough, tiredness and fluid in the lungs.

Infusion-Related Reactions

  *Symptoms of an infusion-related reaction may include one or more of the
    following: the skin getting hot or red (flushing), chills, fever, trouble
    breathing, low blood pressure, wheezing, tightening of the muscles in the
    chest around the airways or a fast heartbeat. The patient’s doctor will
    monitor the patient for infusion-related reactions.

Low Platelet Count

  *Low platelet count may happen during treatment with Kadcyla. Platelets are
    cells in the blood that help the blood clot.

Nerve Damage

  *Symptoms may include numbness and tingling, burning or sharp pain,
    sensitivity to touch, lack of coordination, or muscle weakness or loss of
    muscle function.

Skin Reactions Around the Infusion Site

  *Kadcyla may leak from the vein or needle and cause reactions such as
    redness, tenderness, skin irritation, or pain or swelling at the infusion
    site. If this happens, it is more likely to happen within 24 hours of the

HER2 Testing and Kadcyla

Patients must have a HER2 test to determine if their cancer is HER2-positive
before taking Kadcyla, as benefit has only been shown in patients whose tumors
are HER2-positive.

Most Common Side Effects of Kadcyla

In clinical studies, the most common side effects seen in people taking
Kadcyla were tiredness, nausea, pain that affects the bones, muscles,
ligaments and tendons, low platelet count, headache, liver problems and

The most common severe side effects of Kadcyla were low platelet count, liver
problems, low levels of red blood cells, nerve problems, low levels of
potassium in the blood and tiredness.

Report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch. Patients and caregivers may also report side
effects to Genentech at (888) 835-2555.

For full Prescribing Information and Boxed WARNINGS on Kadcyla, please visit

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. According to
the American Cancer Society, approximately 235,000 people in the United States
will be diagnosed with breast cancer, and 40,000 will die from the disease in
2013. 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 Access Solutions

Genentech is committed to people having access to our medicines. Genentech
Access Solutions is a team of more than 350 Genentech employees who help those
who need our medicines. Our knowledgeable and experienced Specialists can help
patients and medical practices navigate the access and reimbursement process
and provide assistance to eligible patients in the United States who do not
have insurance coverage or who cannot afford their out-of-pocket co-pay costs.
For more information, please visit http://www.Genentech-Access.com.

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


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