Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), announced today positive results from the Phase III GADOLIN
study, which evaluated treatment options for people with indolent
non-Hodgkin’s lymphoma (iNHL) who are refractory to Rituxan®
(rituximab) treatment. At a pre-planned interim analysis, an
independent data monitoring committee determined that the study met
its primary endpoint early. The study showed that people lived
significantly longer without disease worsening or death
(progression-free survival; PFS) when treated with Gazyva
(obinutuzumab) plus bendamustine followed by Gazyva alone, compared
to bendamustine alone. The study was stopped prior to its
protocol-specified final analysis due to the high level of benefit
seen in the Gazyva arm compared to the bendamustine arm. There were
no unexpected adverse events with Gazyva.
“GADOLIN is the first of our pivotal Phase III studies of Gazyva
to be completed in the non-Hodgkin’s lymphoma setting, building on
the positive results we have seen in chronic lymphocytic leukemia,”
said Sandra Horning, M.D., chief medical officer and head of Global
Product Development. “We are delighted that this study could
be evaluated early due to the strength of its data, which we
believe supports Gazyva’s potential in combination with
bendamustine for people whose Rituxan-based therapy failed to
adequately control their disease.”
Data from this pivotal study will be submitted for presentation
at an upcoming medical meeting and to the U.S. Food and Drug
Administration, European Medicines Agency and other health
authorities around the world for approval consideration.
About the GADOLIN Study
GADOLIN (NCT01059630; GA04753g) is a Phase III open-label,
multicenter, randomized two-arm study evaluating Gazyva plus
bendamustine followed by Gazyva alone for up to two years compared
to bendamustine alone in 413 patients with indolent non-Hodgkin’s
lymphoma whose disease progressed during or following Rituxan-based
therapy. The primary endpoint of the study is PFS, with secondary
endpoints including response rate (RR), best response and overall
survival (OS).
About Non-Hodgkin’s Lymphoma
There are two main types of lymphoma: Hodgkin’s lymphoma and
non-Hodgkin’s lymphoma (NHL). NHL has two subsets, aggressive and
indolent (slow-growing).
NHL represents approximately 85 percent of all lymphomas
diagnosed. According to the American Cancer Society, it is expected
that nearly 72,000 people will be diagnosed with NHL in the United
States in 2015, and nearly 20,000 will die from the disease.
Most cases of NHL start in B-lymphocytes, cells that are part of
the body’s immune system and help to defend the body against
infections. B-cell lymphoma develops when these cells become
cancerous and begin to multiply and collect in the lymph nodes or
lymphatic tissues such as the spleen.
About Gazyva
Gazyva is an engineered monoclonal antibody designed to attach
to CD20, a protein found only on B-cells. It attacks targeted cells
both directly and together with the body's immune system. Gazyva is
thought to have an increased ability to induce direct cell death
and induces greater activity in how it recruits the body’s immune
system to attack B-cells (antibody dependent cellular cytotoxicity;
ADCC) when compared to Rituxan. Gazyva was discovered by Roche
Glycart AG, a wholly owned, independent research unit of Roche. In
the United States, Gazyva is part of a collaboration between
Genentech and Biogen Idec.
Gazyva continues to be investigated in a large clinical program,
which includes the head-to-head Phase III GOYA study comparing
Gazyva plus chemotherapy to Rituxan plus chemotherapy in newly
diagnosed (first-line) diffuse large B-cell lymphoma (DLBCL; an
aggressive form of NHL) and the head-to-head Phase III GALLIUM
study comparing Gazyva plus chemotherapy to Rituxan plus
chemotherapy in previously untreated (first-line) indolent
non-Hodgkin’s lymphoma. Additional combination studies are planned
or underway across a range of blood cancers.
Gazyva Indication
Gazyva is a prescription medicine used with the chemotherapy
drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in
adults who have not had previous CLL treatment.
Important Safety Information
Patients must tell their doctor right away about any side
effects they experience. Gazyva can cause side effects that can
become serious or life-threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver
failure and death. If a patient has had history of hepatitis B
infection, Gazyva could cause it to return. Patients should not
receive Gazyva if they have active hepatitis B liver disease. The
patient’s doctor or healthcare team will need to screen for
hepatitis B before, and monitor the patient for hepatitis during
and after, treatment with Gazyva. Sometimes this will require
treatment for hepatitis B. Symptoms of hepatitis include: worsening
of fatigue and yellow discoloration of skin or eyes.
Progressive Multifocal Leukoencephalopathy (PML): PML is
a rare and serious brain infection caused by a virus. PML can be
fatal. A patient’s weakened immune system could put the patient at
risk. The patient’s doctor will watch for symptoms. Symptoms of PML
include: confusion, difficulty talking or walking, dizziness or
loss of balance, and vision problems.
Additional possible serious side effects of Gazyva:
Patients must tell their doctor right away about any side
effects they experience. Gazyva can cause side effects that may
become severe or life threatening, including:
- Infusion Reactions: These side
effects may occur during or within 24 hours of any Gazyva infusion.
Some infusion reactions can be serious, including, but not limited
to, severe allergic reactions (anaphylaxis), acute life-threatening
breathing problems, or other life-threatening infusion reactions.
If a patient has a reaction, the infusion is either slowed or
stopped until the patient’s symptoms are resolved. Most patients
are able to complete infusions and receive medication again.
However, if the infusion reaction is serious, the infusion of
Gazyva will be permanently stopped. The patient’s healthcare team
will take a few steps to help lessen any side effects the patient
may have to the infusion process. The patient may be given
medicines to take before each Gazyva treatment. Signs of infusion
reactions may include: dizziness, nausea, chills, fever, vomiting,
diarrhea, breathing problems, and chest pain
- Tumor Lysis Syndrome (TLS):
Gazyva works to break down cancer cells quickly. As cancer cells
break apart, their contents are released into the blood. These
contents may cause damage to organs and the heart, and may lead to
kidney failure requiring the need for dialysis treatment. The
patient’s doctor may prescribe medication to help prevent TLS. The
patient’s doctor will also conduct regular blood tests to check for
TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and
tiredness
- Infections: While a patient is
taking Gazyva, the patient may develop infections. Some of these
infections may be severe. Fatal infections have been reported, so
the patient should be sure to talk to the doctor if the patient
thinks the patient has one. Patients with active infection should
not be treated with Gazyva. Infections may continue even after the
patient stops taking Gazyva. The patient’s doctor may prescribe
medications to help prevent infections. Symptoms of infection
include fever and cough
- Low White Blood Cell Count: When
a patient has an abnormally low count of infection-fighting white
blood cells, it is called neutropenia. While the patient is taking
Gazyva, the patient’s doctor will do blood work to check the
patient’s white blood cell counts. Neutropenia can develop during
or after treatment with Gazyva. It may also last for more than one
month. If a patient’s white blood cell count is low, the patient’s
doctor may prescribe medication to help prevent infections
- Low Platelet Count: Platelets
help stop bleeding or blood loss. Gazyva may reduce the number of
platelets the patient has in the blood. This may affect the
clotting process. While the patient is taking Gazyva, the patient’s
doctor will do blood work to check the patient’s platelet
count
Most common side effects of Gazyva
The most common side effects of Gazyva are infusion reactions,
low white blood cell counts, low platelet counts, low red blood
cell counts, fever, cough, nausea, and diarrhea.
Before receiving Gazyva, patients should talk to their doctor
about:
Immunizations: Before receiving Gazyva therapy, the
patient should tell the patient’s healthcare provider if the
patient has recently received or is scheduled to receive a vaccine.
Patients who are treated with Gazyva should not receive live
vaccines.
Pregnancy: A patient should tell the doctor if the
patient is pregnant, plans to become pregnant, or is breastfeeding.
It is not known if Gazyva may harm the patient’s unborn baby or
pass into the patient’s breast milk. The patient should use birth
control while using Gazyva and for 12 months after treatment.
Mothers who have been exposed to Gazyva during pregnancy should
discuss the safety and timing of live virus vaccinations for their
infants with their child’s healthcare providers. The patient should
speak to the doctor about discontinuing Gazyva if the patient is
breastfeeding.
Patients must tell their doctor about any side effect that
bothers them or that does not go away.
These are not all of the possible side effects of Gazyva. For
more information, patients should ask their doctor or
pharmacist.
Gazyva is available by prescription only.
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.Gazyva.com for the full
Prescribing Information, including Boxed WARNINGS, for additional
Important Safety Information.
Rituxan Indications
Rituxan (rituximab) is indicated for the treatment of patients
with:
- Relapsed or refractory, low-grade or
follicular, CD20-positive, B-cell NHL as a single agent
- Previously untreated follicular,
CD20-positive, B-cell NHL in combination with first-line
chemotherapy and, in patients achieving a complete or partial
response to Rituxan in combination with chemotherapy, as
single-agent maintenance therapy
- Non-progressing (including stable
disease), low-grade, CD20-positive, B-cell NHL, as a single agent,
after first-line CVP chemotherapy
- Previously untreated diffuse large
B-cell, CD20-positive NHL in combination with CHOP or other
anthracycline-based chemotherapy regimens
- Previously untreated and previously
treated CD20-positive CLL in combination with fludarabine and
cyclophosphamide (FC)
Rituxan is not recommended for use in patients with
severe, active infections.
Important Safety Information:
Rituxan can cause serious side effects that can lead to death,
including:
- Infusion Reactions: may occur
during or within 24 hours of the infusion. The patient’s doctor
should give the patient medicines before their treatment. Symptoms
can include hives, rash, itching, facial or oral swelling, sudden
cough, shortness of breath, difficulty breathing, weakness,
dizziness, feeling faint, racing heart or chest pain
- Severe Skin and Mouth Reactions:
symptoms can include painful sores, ulcers, or blisters on the
skin, lips or mouth; peeling skin; rash; or pustules
- Hepatitis B Virus (HBV)
Reactivation: may cause serious liver problems including liver
failure and death. If patients have had hepatitis B or are carriers
of HBV, receiving Rituxan could cause the virus to become an active
infection again. Patient should not receive Rituxan if they have
active HBV liver disease. The patient’s doctor will do blood tests
to check for HBV infection prior to treatment and will monitor the
patient during and for several months following their
treatment
- Progressive Multifocal
Leukoencephalopathy (PML): a rare, serious brain infection that
can lead to severe disability and death and for which there is no
known prevention, treatment or cure. Symptoms can include
difficulty thinking, loss of balance, changes in speech or walking,
weakness on one side of the body or blurred or lost vision
What are the additional possible serious side effects of
Rituxan?
Patients must tell their doctor right away about any side
effects they experience. Rituxan can cause serious side effects
that can lead to death, including:
- Tumor Lysis Syndrome (TLS): may
cause kidney failure and the need for dialysis treatment, abnormal
heart rhythm and can lead to death. The patient’s doctor may give
the patient medicines before their treatment to help prevent
TLS
- Serious Infections: can happen
during and after treatment and can lead to death. These infections
may be bacterial, fungal or viral. Symptoms can include fever; cold
or flu symptoms; earache or headache; pain during urination; white
patches in the mouth or throat; cuts or scrapes that are red, warm,
swollen or painful
- Heart Problems: symptoms can
include chest pain and irregular heartbeats that may require
treatment. The patient’s doctor may need to stop their
treatment
- Kidney Problems: the patient’s
doctor should do blood tests to check how well the patient’s
kidneys are working
- Stomach and Serious Bowel
Problems: can include blockage or tears in the bowel that can
lead to death. Stomach area pain during treatment can be a
symptom
- Low Blood Cell Counts: the
patient’s blood cell counts may be monitored during treatment
The most common side effects of Rituxan are infusion reactions,
chills, infections, body aches, tiredness and low white blood
cells.
Patients must tell their doctor if they are pregnant, plan to
become pregnant or are breastfeeding. It is not known if Rituxan
may harm the patient’s unborn baby or pass into the patient’s
breast milk. Women should use birth control while using Rituxan and
for 12 months after treatment.
Patients must tell their doctor about any side effect that
bothers them or that does not go away.
These are not all of the possible side effects of Rituxan. For
more information, patients should ask their doctor or
pharmacist.
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 see the Rituxan full Prescribing Information, including
Most Serious Side Effects, for additional important safety
information at http://www.Rituxan.com.
About Genentech In Hematology
For more than 20 years, Genentech has been developing medicines
with the goal to redefine treatment in hematology. Today, we’re
investing more than ever in our effort to bring innovative
treatment options to people with diseases of the blood. Genentech’s
pipeline of potential hematology medicines includes an
antibody-drug conjugate (anti-CD79b; polatuzumab vedotin), a small
molecule antagonist of MDM2 (RG7388) and in collaboration with
AbbVie, a small molecule BCL-2 inhibitor (GDC-0199/ABT-199;
venetoclax). Genentech’s dedication to developing novel molecules
in hematology expands beyond oncology, with the development of the
investigational hemophilia A treatment ACE910.
About Genentech
Founded more than 35 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.
GenentechMedia Contact:Emmy Wang, 650-467-6800orAdvocacy
Contact:Jen Mills, 650-467-6722orInvestor Contacts:Nina Goworek,
650-467-8737Karl Mahler, 011 41 61 687 8503
Roche (QX) (USOTC:RHHBY)
Gráfica de Acción Histórica
De Ene 2025 a Feb 2025
Roche (QX) (USOTC:RHHBY)
Gráfica de Acción Histórica
De Feb 2024 a Feb 2025
