FDA Grants Genentech’s Cancer Immunotherapy TECENTRIQ™ (atezolizumab) Accelerated Approval for People with a Specific Type of Advanced Bladder Cancer

– First and only anti-PDL1 cancer immunotherapy approved by the FDA –

– First FDA-approved treatment for people with a specific type of
bladder cancer in more than 30 years –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the U.S. Food and Drug Administration (FDA) granted
accelerated approval to TECENTRIQ™ (atezolizumab) for the treatment of
people with locally advanced or metastatic urothelial carcinoma (mUC)
who have disease progression during or following platinum-based
chemotherapy, or whose disease has worsened within 12 months of
receiving platinum-based chemotherapy before surgery (neoadjuvant) or
after surgery (adjuvant). Urothelial carcinoma accounts for 90 percent
of all bladder cancers and can also be found in the renal pelvis, ureter
and urethra.

“TECENTRIQ is a new medicine that can work with the immune system to
treat people with a type of bladder cancer that progressed after
platinum-based chemotherapy,” said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. “We thank the
scientists, doctors, patients and their families who made it possible to
bring TECENTRIQ to people with advanced urothelial carcinoma.”

“Even though bladder cancer is the fifth most commonly diagnosed cancer
in the United States, it hasn’t received the same attention within the
cancer community as other common cancers,” said Diane Zipursky Quale,
president and co-founder, Bladder Cancer Advocacy Network. “TECENTRIQ is
a new medicine for people whose locally advanced or metastatic bladder
cancer has progressed on platinum-based chemotherapy and may have
limited treatment options.”

The FDA’s Accelerated Approval Program allows conditional approval of a
medicine that fills an unmet medical need for a serious condition, based
on early evidence suggesting clinical benefit. The indication for
TECENTRIQ is approved under accelerated approval based on tumor response
rate and duration of response. Continued approval for this indication
may be contingent upon verification and description of clinical benefit
in confirmatory trials. Today’s approval of TECENTRIQ is based on the
Phase II IMvigor 210 study.

Possible serious side effects with TECENTRIQ include, but are not
limited to, lung problems (pneumonitis), liver problems (hepatitis),
intestinal problems (colitis), hormone gland problems (especially the
pituitary, thyroid, adrenal glands and pancreas), nervous system
problems (neuropathy and meningoencephalitis), eye problems, severe
infections and severe infusion reactions. Additional information on
these and other side effects can be found below.

TECENTRIQ will be available to people in the United States within one to
two weeks. For those who qualify, Genentech plans to offer patient
assistance programs for people taking TECENTRIQ through Genentech Access
Solutions. Doctors can contact Genentech Access Solutions at (888)
249-4918. More information is also available at http://www.Genentech-Access.com.

Genentech is also evaluating TECENTRIQ in a confirmatory Phase III study
(IMvigor 211), which compares TECENTRIQ to chemotherapy in people whose
bladder cancer has progressed on at least one prior platinum-containing

About the IMvigor 210 study

IMvigor 210 is an open-label, multicenter, two-cohort Phase II study
that evaluated the safety and efficacy of TECENTRIQ in people with
locally advanced or mUC, regardless of PD-L1 expression. People in a
cohort of the study whose disease had progressed during or following
previous treatment with a platinum-based chemotherapy regimen, or who
had disease progression within 12 months of treatment with a
platinum-based neoadjuvant or adjuvant chemotherapy regimen (n=310)
received a 1200-mg intravenous dose of TECENTRIQ on day one of 21-day
cycles until unacceptable toxicity or either radiographic or clinical
progression. The primary endpoint of the study was objective response
rate (ORR) as assessed by an independent review facility (IRF) using
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary
endpoints included duration of response (DOR). A summary of the efficacy
and safety data from the IMvigor 210 study that supports this
accelerated approval is included below. The median follow-up time for
this cohort was 14.4 months.

    All Patients   PD-L1 Expression Subgroups

of < 5%


of ≥ 5% in ICs1

Number of IRF-assessed Confirmed Responders   46   20   26
ORR (%)

(95% CI)


(11.1, 19.3)


(5.9, 14.3)


(17.7, 35.7)

Complete Response (CR) (%)   5.5%   2.4%   12.0%
Partial Response (PR) (%)   9.4%   7.1%   14.0%
Median DOR, months (range)   Not Reached

(2.1+, 13.8+)

  12.7 months

(2.1+, 12.7)

  Not Reached

(4.2, 13.8+)

1 PD-L1 expression in tumor-infiltrating immune cells

+ Denotes a censored value

In a subset of people in the IMvigor 210 study with disease progression
following neoadjuvant or adjuvant platinum-containing therapy (n=59),
TECENTRIQ shrank tumors (ORR) in 22.0 percent (95 percent CI: 12.3,
34.7) of people.

The most common Grade 3-4 adverse reactions (≥ 2 percent) were: urinary
tract infection (9 percent), anemia (8 percent), fatigue (6 percent),
dehydration, intestinal obstruction (partial or complete blockage of the
bowel), urinary obstruction, hematuria (blood in the urine; 3 percent),
dyspnea (difficulty breathing; 4 percent), acute kidney injury,
abdominal pain (pain in stomach area; 4 percent), venous thromboembolism
(blood clots in the vein), sepsis (blood infection) and pneumonia (lung
infection). Three people (0.9 percent) experienced either sepsis,
pneumonitis (lung problems) or intestinal obstruction, which led to
death. TECENTRIQ was discontinued for adverse reactions in 3.2 percent
(10) of the 310 patients.

About metastatic urothelial carcinoma

According to the American Cancer Society (ACS), it is estimated that
more than 76,000 Americans will be diagnosed with bladder cancer in
2016. About 11 percent of new diagnoses are made when bladder cancer is
in advanced stages. There is a dramatic difference in survival rates
between early and advanced bladder cancer. Approximately 96 percent of
people will live five or more years when diagnosed with the earliest
stage of the disease, compared to 39 percent when diagnosed in advanced
stages (stage III-IV) of the disease. Men are about three to four times
more likely to get bladder cancer during their lifetime than women.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people
access the Genentech medicines they are prescribed, regardless of their
ability to pay. The team of 350 in-house specialists at Access Solutions
is dedicated to helping people navigate the access and reimbursement
process, and to providing assistance to eligible patients in the United
States who are uninsured or cannot afford the out-of-pocket costs for
their medicine. To date, the team has helped more than 1.4 million
patients access the medicines they need. Please contact Access Solutions
(866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com
for more information.

About atezolizumab

Atezolizumab is a monoclonal antibody designed to bind with a protein
called PD-L1. Atezolizumab is designed to bind to PD-L1 expressed on
tumor cells and tumor-infiltrating immune cells, blocking its
interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1,
atezolizumab may enable the activation of T cells. Atezolizumab may also
affect normal cells.

TECENTRIQ U.S. Indications (pronounced ‘tē-SEN-trik’)

TECENTRIQ™ is a prescription medicine used to treat:

  • A type of bladder cancer called urothelial carcinoma. TECENTRIQ may be
    used when bladder cancer has spread or cannot be removed by surgery
    (advanced urothelial carcinoma) and,
  • You have tried chemotherapy that contains platinum, and it did not
    work or is no longer working.

It is not known if TECENTRIQ is safe and effective in children.

Important Safety Information

Important Information About TECENTRIQ

TECENTRIQ can cause the immune system to attack normal organs and
tissues in many areas of the body and can affect the way they work.
These problems can sometimes become serious or life-threatening and can
lead to death.

Getting medical treatment right away may help keep these problems
from becoming more serious.
The healthcare provider may treat the
patient with corticosteroid or hormone replacement medicines. The
healthcare provider may delay or completely stop treatment with
TECENTRIQ if severe side effects occur.

Patients should call or see their healthcare provider right away if
they get any symptoms of the following problems or these symptoms get

TECENTRIQ can cause serious side effects, including:

  • Lung Problems (pneumonitis) – Signs and symptoms of pneumonitis
    may include: new or worsening cough, shortness of breath, or chest pain
  • Liver Problems (hepatitis) – Signs and symptoms of hepatitis
    may include: yellowing of the skin or the whites of the eyes, severe
    nausea or vomiting, pain on the right side of the stomach area
    (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising
    more easily than normal, feeling less hungry than usual
  • Intestinal Problems (colitis) – Signs and symptoms of colitis
    may include: diarrhea (loose stools) or more bowel movements
    than usual, blood in the stools or dark, tarry, sticky stools,
    severe stomach area (abdomen) pain or tenderness
  • Hormone Gland Problems (especially the pituitary, thyroid, adrenal
    glands and pancreas)
    Signs and symptoms that the hormone
    glands are not working properly may include: headaches that will not
    go away or unusual headaches, extreme tiredness, weight gain or weight
    loss, dizziness or fainting, feeling more hungry or thirsty than
    usual, hair loss, changes in mood or behavior, such as decreased sex
    drive, irritability, or forgetfulness, feeling cold, constipation,
    voice gets deeper, urinating more often than usual, nausea or
    vomiting, stomach area (abdomen) pain
  • Nervous System Problems (neuropathy, meningoencephalitis)
    Signs of nervous system problems may include: severe muscle weakness,
    numbness or tingling in hands and feet, fever, confusion, changes in
    mood or behavior, extreme sensitivity to light, neck stiffness
  • Inflammation of the Eyes – Symptoms may include blurry vision,
    double vision, other vision problems, eye pain or redness
  • Severe Infections – Symptoms of infection may include: fever,
    cough, frequent urination, flu-like symptoms, pain when urinating
  • Severe Infusion Reactions – Signs and symptoms of infusion
    reactions may include: chills or shaking, itching or rash, flushing,
    shortness of breath or wheezing, dizziness, fever, feeling like
    passing out, back or neck pain, facial swelling

The most common side effects of TECENTRIQ include:

  • feeling tired
  • decreased appetite
  • nausea
  • urinary tract infection
  • fever
  • constipation

These are not all the possible side effects of TECENTRIQ. Patients
should ask their healthcare provider or pharmacist for more information.

Before receiving TECENTRIQ, patients should tell their healthcare
provider about all of their medical conditions, including if they:

  • have immune system problems such as Crohn’s disease, ulcerative
    colitis, or lupus; have had an organ transplant; have lung or
    breathing problems; have liver problems; have a condition that affects
    the nervous system, such as Myasthenia Gravis or Guillain-Barre
    syndrome; or are being treated for an infection.
  • are pregnant or plan to become pregnant.

    • TECENTRIQ can harm an unborn baby.
    • If patients are able to become pregnant, they should use an
      effective method of birth control during treatment and for at
      least 5 months after the last dose of TECENTRIQ.
  • are breastfeeding or plan to breastfeed.

    • It is not known if TECENTRIQ passes into the breast milk.
    • Do not breastfeed during treatment and for at least 5 months after
      the last dose of TECENTRIQ.

Patients should tell their healthcare provider about all of the
medicines they take,
including prescription and over-the-counter
medicines, vitamins and herbal supplements.

Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555.

Please visit http://www.TECENTRIQ.com
for the TECENTRIQ full Prescribing Information for additional Important
Safety Information.

About Genentech in Personalized Cancer Immunotherapy

For more than 30 years, Genentech has been developing medicines with the
goal to redefine treatment in oncology. Today, we’re investing more than
ever to bring personalized cancer immunotherapy (PCI) to people with
cancer. The goal of PCI is to provide each person with a treatment
tailored to harness his or her own immune system to fight cancer.
Genentech is studying more than 20 investigational medicines, nine of
which are in clinical trials. In every study we are evaluating
biomarkers to identify which people may be appropriate candidates for
our medicines. For more information visit http://www.gene.com/immunotherapy.

About Genentech

Founded 40 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 http://www.gene.com.


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