FDA Grants Priority Review to Genentech's Cancer Immunotherapy TECENTRIQ (Atezolizumab) for Initial Treatment of …

Source: FDA Grants Priority Review to Genentech's Cancer Immunotherapy TECENTRIQ (Atezolizumab) for Initial Treatment of …

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) has
accepted the company’s supplemental Biologics License Application (sBLA)
and granted Priority Review for TECENTRIQ^® (atezolizumab), in
combination with Avastin^® (bevacizumab), paclitaxel and
carboplatin (chemotherapy), for the initial (first-line) treatment of
people with metastatic non-squamous non-small cell lung cancer (NSCLC).
The FDA is expected to make a decision on approval by September 5, 2018.
A Priority Review designation is granted to medicines that the FDA has
determined to have the potential to provide significant improvements in
the treatment, prevention or diagnosis of a disease.

“Our Phase III results showed TECENTRIQ in combination with Avastin,
paclitaxel and carboplatin has the potential to provide a significant
survival benefit in the initial treatment of metastatic non-squamous
non-small cell lung cancer,” said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. “We are working closely
with the FDA to bring this treatment regimen to people with this type of
lung cancer as soon as possible.”

This sBLA is based on results from the Phase III IMpower150 study, which
met its co-primary endpoints of overall survival (OS) and
progression-free survival (PFS) in the initial treatment of people with
advanced non-squamous NSCLC. The safety profile of the combination was
consistent with the safety profiles of the individual medicines, and no
new safety signals were identified.

TECENTRIQ is currently approved by the FDA to treat people with
metastatic NSCLC who have disease progression during or following
platinum-containing chemotherapy, and have progressed on an appropriate
FDA-approved targeted therapy if their tumor has ALK or EGFR gene
abnormalities.

About the IMpower150 study

IMpower150 is a multicenter, open-label, randomized, controlled Phase
III study evaluating the efficacy and safety of TECENTRIQ in combination
with carboplatin and paclitaxel with or without Avastin in people with
stage IV non-squamous NSCLC who had not been treated with chemotherapy
for their advanced disease. It enrolled 1,202 people, of which those
with ALK and EGFR mutations were excluded from the primary
intention-to-treat (ITT) analysis. People were randomized (1:1:1) to
receive:

• TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
• TECENTRIQ and Avastin plus carboplatin and paclitaxel (Arm B), or
• Avastin plus carboplatin and paclitaxel (Arm C, control arm).

The co-primary endpoints were OS and PFS, as determined by the
investigator using Response Evaluation Criteria in Solid Tumors Version
1.1 (RECIST v1.1). The primary analysis of the co-primary PFS endpoint
in IMpower150 was assessed in two populations: all randomized people
without an ALK or EGFR genetic mutation (intention-to-treat wild-type)
and in a subgroup of people who had a specific biomarker (T-effector
“Teff” gene signature expression). The co-primary OS endpoint was
assessed in all randomized people without an ALK or EGFR genetic
mutation (intention-to-treat wild-type). Key secondary endpoints
included investigator-assessed PFS and OS, safety in the ITT population
and in EGFR and ALK mutation subgroups.

About lung cancer

According to the American Cancer Society, it is estimated that more than
234,000 Americans will be diagnosed with lung cancer in 2018, and NSCLC
accounts for 85 percent of all lung cancers. It is estimated that
approximately 60 percent of lung cancer diagnoses in the United States
are made when the disease is in the advanced stages.

About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab)
combination

There is a strong scientific rationale to support further investigation
of TECENTRIQ plus Avastin in combination. We are investigating this
combination in a broad range of cancers, including first-line advanced
NSCLC. Avastin, in addition to its anti-angiogenic effects, may further
enhance TECENTRIQ’s ability to restore anti-cancer immunity by
inhibiting VEGF-related immunosuppression, promoting T-cell tumor
infiltration and enabling priming and activation of T-cell responses
against tumor antigens.

About TECENTRIQ^® (atezolizumab)

TECENTRIQ is a monoclonal antibody designed to bind with a protein
called PD-L1. TECENTRIQ 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, TECENTRIQ may
enable the re-activation of T cells. TECENTRIQ may also affect normal
cells.

About Avastin^® (bevacizumab)

Avastin is a prescription-only medicine that is a solution for
intravenous infusion. It is a biologic antibody designed to specifically
bind to a protein called vascular endothelial growth factor (VEGF) that
plays an important role throughout the lifecycle of the tumor to develop
and maintain blood vessels, a process known as angiogenesis. Avastin is
designed to interfere with the tumor blood supply by directly binding to
the VEGF protein to prevent interactions with receptors on blood vessel
cells. The tumor blood supply is thought to be critical to a tumor’s
ability to grow and spread in the body (metastasize).

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

TECENTRIQ is a prescription medicine used to treat:

a type of bladder and urinary tract cancer called urothelial
carcinoma.

• TECENTRIQ may be used when your bladder cancer:
  • has spread or cannot be removed by surgery (advanced urothelial
    carcinoma), and
  • you are not able to take chemotherapy that contains a medicine
    called cisplatin, or
  • you have tried chemotherapy that contains platinum, and it did not
    work or is no longer working

The approval of TECENTRIQ in these patients is based on a study that
measured response rate and duration of response. There is an ongoing
study to confirm clinical benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

• TECENTRIQ may be used when your lung cancer:
  • has spread or grown, and
  • you have tried chemotherapy that contains platinum, and it did not
    work or is no longer working

If your tumor has an abnormal EGFR or ALK gene, you should have also
tried an FDA-approved therapy for tumors with these abnormal genes, 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.

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

TECENTRIQ can cause serious side effects, including:

• Lung problems (pneumonitis) – signs and symptoms may include
  new or worsening cough, shortness of breath, and 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, and 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 or mucous in the stools or dark, tarry, sticky stools,
  and severe stomach area (abdomen) pain or tenderness
• Hormone gland problems (especially the thyroid, adrenal glands,
  pancreas, and pituitary) – 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, and stomach area (abdomen) pain
• Problems in other organs – signs and symptoms may include
  severe muscle weakness, numbness or tingling in hands or feet,
  confusion, blurry vision, double vision, or other vision problems,
  changes in mood or behavior, extreme sensitivity to light, neck
  stiffness, eye pain or redness, skin blisters or peeling, chest pain,
  irregular heartbeat, shortness of breath, or swelling of the ankles
• Severe infections – signs and symptoms of infection may include
  fever, cough, flu-like symptoms, pain when urinating, and frequent
  urination or back pain
• Severe infusion reactions – signs and symptoms of infusion
  reactions may include chills or shaking, itching or rash, flushing,
  shortness of breath or wheezing, swelling of the face or lips,
  dizziness, fever, feeling like passing out, and back or neck pain

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

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
  their 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 the
medicines they take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.

The most common side effects of TECENTRIQ in people with urothelial
carcinoma include:

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

The most common side effects of TECENTRIQ in people with non-small
cell lung cancer include:

• feeling tired
• decreased appetite
• muscle pain
• cough
• shortness of breath

TECENTRIQ may cause fertility problems in females, which may affect the
ability to have children. Patients should talk to their healthcare
provider if they have concerns about fertility.

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

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Report side effect to Genentech at 1-888-835-2555.

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

Avastin Indications:

• Metastatic colorectal cancer (mCRC) for first- or second-line
  treatment in combination with intravenous 5-fluorouracil–based
  chemotherapy. It is also approved to treat mCRC for second-line
  treatment when used with fluoropyrimidine-based (combined with
  irinotecan or oxaliplatin) chemotherapy after cancer progresses
  following a first-line treatment that includes Avastin.
  • Avastin is not approved for use after the primary treatment of
    colon cancer that has not spread to other parts of the body.
• Advanced nonsquamous non–small cell lung cancer (NSCLC) in
  combination with carboplatin and paclitaxel in people who have not
  received chemotherapy for their advanced disease.
• Metastatic kidney cancer (mRCC) when used with interferon alfa.
• Glioblastoma (GBM) in adult patients whose cancer has
  progressed after prior treatment (recurrent or rGBM).
• Advanced cervical cancer (CC) in combination with paclitaxel
  and cisplatin or paclitaxel and topotecan is approved to treat
  persistent, recurrent, or metastatic cancer of the cervix.
• Recurrent ovarian cancer (rOC). Avastin in combination with
  paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved
  to treat platinum-resistant recurrent epithelial ovarian, fallopian
  tube or primary peritoneal cancer (prOC) in women who received no more
  than two prior chemotherapy treatments. Avastin, either in combination
  with carboplatin and paclitaxel or with carboplatin and gemcitabine,
  followed by Avastin alone, is approved for the treatment of patients
  with platinum-sensitive recurrent epithelial ovarian, fallopian tube,
  or primary peritoneal cancer (psOC).

Possible serious side effects

Everyone reacts differently to Avastin therapy. So it’s important to
know what the side effects are. Although some people may have a
life-threatening side effect, most do not. Their doctor will stop
treatment if any serious side effects occur. Patients should talk to
their doctor if there are any signs of these side effects.

Most serious side effects (not common, but sometimes fatal):

• GI perforation.A hole that
  develops in the stomach or intestine. Symptoms include pain in the
  abdomen, nausea, vomiting, constipation, or fever
• Wounds that don’t heal.A
  cut made during surgery can be slow to heal or may not fully heal.
  Avastin should not be used for at least 28 days before or after
  surgery and until surgicalwounds are fully healed
• Serious bleeding.This
  includes vomiting or coughing up blood; bleeding in the stomach,
  brain, or spinal cord; nosebleeds; and vaginal bleeding. If a patient
  has recently coughed up blood or had serious bleeding, they should be
  sure to tell their doctor

Other possible serious side effects

• Abnormal passage in the body. This type of passage—known as a
  fistula—is an irregular connection from one part of the body to
  another and can sometimes be fatal
• Severe high blood pressure. Blood pressure that severely spikes
  or shows signs of affecting the brain. Blood pressure should be
  monitored every 2 to 3 weeks while on Avastin and after stopping
  treatment
• Kidney problems. These may be caused by too much protein in the
  urine and can sometimes be fatal
• Infusion reactions. These were uncommon with the first dose
  (less than 3% of patients). 0.2% of patients had severe reactions.
  Infusion reactions include high blood pressure or severe high blood
  pressure that may lead to stroke, trouble breathing, decreased oxygen
  in red blood cells, a serious allergic reaction, chest pain, headache,
  tremors, and excessive sweating. The patient’s doctor or nurse will
  monitor for signs of infusion reactions
• Severe stroke or heart problems. These may include blood clots,
  mini-stroke, heart attack, chest pain, and the heart may become too
  weak to pump blood to other parts of the body (congestive heart
  failure). These can sometimes be fatal
• Nervous system and vision problems. Signs include headache,
  seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients
experienced the following side effects:

• High blood pressure
• Too much protein in the urine
• Nosebleeds
• Rectal bleeding
• Back pain
• Headache
• Taste change
• Dry skin
• Inflammation of the skin
• Inflammation of the nose
• Watery eyes

Avastin is not for everyone

Patients should talk to their doctor if they are:

• Undergoing surgery. Avastin should not be used for 28 days
  before or after surgery and until surgical wounds are fully healed
• Pregnant or think they are pregnant. Data have shown that
  Avastin may harm a woman’s unborn baby. Birth control should be used
  while patients are on Avastin. If Avastin is stopped, patients should
  keep using birth control for 6 months before trying to become pregnant
• Planning to become pregnant. Taking Avastin could cause a
  woman’s ovaries to stop working and may impair her ability to have
  children
• Breastfeeding. Breastfeeding while on Avastin may harm the baby
  and is therefore not recommended

Patients should talk with their doctor if they have any questions about
their condition or treatment.

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.

For full Prescribing Information on Avastin please visit http://www.avastin.com.

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, 10 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/cancer-immunotherapy.

About Genentech in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and
we are committed to developing new approaches, medicines and tests that
can help people with this deadly disease. Our goal is to provide an
effective treatment option for every person diagnosed with lung cancer.
We currently have four approved medicines to treat certain kinds of lung
cancer and more than 10 medicines being developed to target the most
common genetic drivers of lung cancer or to boost the immune system to
combat the disease.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious and 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.

Published at Mon, 07 May 2018 05:00:56 +0000