Thursday, Jun 22, 2017

FDA Approves Rituxan Hycela (Rituximab and Hyaluronidase Human) for Subcutaneous Injection in Certain Blood Cancers

Treatment can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous Rituxan

South San Francisco, CA -- June 22, 2017 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved RITUXAN HYCELA™ (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL). This new treatment includes the same monoclonal antibody as intravenous Rituxan^® (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin.

“With today’s approval of RITUXAN HYCELA, people with three of the most common blood cancers now have a new treatment option which provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “People who benefit from Rituxan may receive years of repeated treatments for their blood cancer, so an option that reduces the administration time can be important.”

The FDA approval is based on results from clinical studies, which demonstrated that subcutaneous administration of RITUXAN HYCELA resulted in non-inferior levels of rituximab in the blood (pharmacokinetics) and comparable clinical efficacy outcomes compared to intravenous Rituxan. One of the studies showed the majority (77 percent) of patients preferred RITUXAN HYCELA over intravenous Rituxan, with the most common reason being that administration required less time in the clinic. People can only receive RITUXAN HYCELA after at least one full dose of intravenous Rituxan.

With the exception of local skin (cutaneous) reactions, the incidence and profile of adverse reactions for RITUXAN HYCELA were comparable with those for intravenous Rituxan. The most common (≥20 percent) adverse reactions observed with RITUXAN HYCELA in people with follicular lymphoma were infections, low white blood cell count (neutropenia), nausea, constipation, cough and fatigue. The most common adverse reactions in people with DLBCL were infections, neutropenia, hair loss (alopecia), nausea and low red blood cell count (anemia). The most common adverse reactions in people with CLL were infections, neutropenia, nausea, low platelet count (thrombocytopenia), fever (pyrexia), vomiting and reddening of the skin (erythema) at the injection site.

RITUXAN HYCELA will be available to people in the United States within one to two weeks, and intravenous Rituxan will continue to be available. For those who qualify, Genentech plans to offer patient assistance programs for people taking RITUXAN HYCELA 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. 

About the RITUXAN HYCELA Clinical Development Program

The approval of RITUXAN HYCELA is based on results from clinical studies that together represented nearly 2,000 people. The studies were the following:

• SABRINA (NCT01200758): Phase III combination with chemotherapy and maintenance study in previously untreated follicular lymphoma
• SAWYER (NCT01292603): Phase Ib study in previously untreated chronic lymphocytic leukemia (CLL)
• MabEase (NCT01649856): Phase III study in previously untreated diffuse large B-cell lymphoma (DLBCL)
• PrefMab (NCT01724021): Phase III patient preference study in previously untreated follicular lymphoma and DLBCL

About Follicular Lymphoma

Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL), accounting for about one in five cases of NHL. It is considered incurable and relapse is common. In the United States, it is estimated that more than 14,000 new cases of follicular lymphoma will be diagnosed in 2017.

About Diffuse Large B-Cell Lymphoma (DLBCL)

DLBCL is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. As many as 40 percent of patients will relapse, at which point their prognosis is poor. In the United States, it is estimated that more than 24,000 new cases of DLBCL will be diagnosed in 2017.

About Chronic Lymphocytic Leukemia (CLL)

CLL is the most common type of adult leukemia, and in 2017, it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.

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 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 1.5 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 RITUXAN HYCELA

RITUXAN HYCELA is a combination of rituximab and Halozyme Therapeutics’ proprietary hyaluronidase human. Rituximab is the same monoclonal antibody in intravenous Rituxan and is designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells together with the body’s immune system. Halozyme’s hyaluronidase human is a well-established enzyme that facilitates the delivery of a large volume of medicine under the skin.

RITUXAN HYCELA can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous Rituxan. Patients should be observed for at least 15 minutes following RITUXAN HYCELA. All patients must first receive at least one full dose of Rituxan by intravenous infusion without severe adverse reactions before they can receive RITUXAN HYCELA due to the higher risk of certain severe adverse reactions during the first infusion.

Rituxan was discovered by Biogen and is part of a collaboration between Genentech and Biogen in the United States.

RITUXAN HYCELA Indications

RITUXAN HYCELA™ (rituximab/hyaluronidase human) is a prescription medicine used to treat adults with:

• Follicular Lymphoma (FL) as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
• Follicular Lymphoma as an initial treatment with chemotherapy and, in patients whose initial treatment was successful, as a single-agent follow-up therapy
• Follicular Lymphoma as a single-agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
• Diffuse Large B-Cell Lymphoma (DLBCL) as an initial treatment in combination with CHOP or other anthracycline-based chemotherapy regimens
• Chronic Lymphocytic Leukemia (CLL) in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred

Patients can only receive RITUXAN HYCELA after at least one full dose of intravenous (IV) Rituxan ^® (rituximab). Read the IV Rituxan Medication Guide for more information about severe infusion reactions, which usually happen during the first dose with IV Rituxan.

RITUXAN HYCELA is not for use to treat medical conditions other than cancers.

It is not known if RITUXAN HYCELA is safe and effective in children.

Important Safety Information

RITUXAN HYCELA can cause serious side effects that can lead to death, including:

• Severe skin and mouth reactions: Patients must tell their healthcare provider or get medical help right away if they get any of these symptoms at any time during treatment with RITUXAN HYCELA: painful sores or ulcers on the skin, lips, or in the mouth; blisters; peeling skin; rash or pustules.
• Hepatitis B virus (HBV) reactivation: Before a patient receives RITUXAN HYCELA, the patient’s doctor will do blood tests to check for HBV infection. If the patient has had hepatitis B or is a carrier of hepatitis B virus, receiving RITUXAN HYCELA could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure and death. The patient’s healthcare provider will monitor for hepatitis B infection during and for several months after the patient stops receiving RITUXAN HYCELA. Patients must tell their healthcare provider right away if they get worsening tiredness, or yellowing of the skin or white part of the eyes during treatment with RITUXAN HYCELA.
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive RITUXAN HYCELA. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Patients must tell their healthcare provider right away if they have any new or worsening symptoms or if anyone close to them notices these symptoms: confusion; dizziness or loss of balance; difficulty walking or talking; decreased strength or weakness on one side of the body; vision problems, such as blurred or loss of vision.
• Serious allergic reactions and other severe reactions:

Serious allergic reactions, and reactions due to release of certain substances by the body that can lead to death, can happen with rituximab products, including RITUXAN HYCELA.

Skin reactions at or near the injection site (local), including injection site reactions can happen with RITUXAN HYCELA. Symptoms at or near the injection site may include: pain, swelling, hardness, redness, bleeding, itching, and rash. These reactions sometimes happen more than 24 hours after an injection of RITUXAN HYCELA.

Patients must tell their healthcare provider or get medical help right away if they get any of these symptoms during or after an injection of RITUXAN HYCELA: hives (red itchy welts) or rash; itching; swelling of the lips, tongue, throat, or face; sudden cough; shortness of breath, difficulty breathing, or wheezing; weakness; dizziness or feeling faint; palpitations (feeling the heart is racing or fluttering); chest pain; fever; chills or shaking chills.

What are possible side effects of RITUXAN HYCELA?

RITUXAN HYCELA can cause serious side effects, including:

• Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause the patient to have kidney failure, the need for dialysis treatment, and an abnormal heart rhythm. TLS can happen within 12 to 24 hours after an injection of RITUXAN HYCELA. The patient’s healthcare provider may do blood tests to check for TLS. The patient’s healthcare provider may give medicine to help prevent TLS. Patients must tell their healthcare provider right away if they have any of the following signs or symptoms of TLS: nausea, vomiting, diarrhea, or lack of energy.
• Serious Infections: Serious infections can happen during and after treatment with RITUXAN HYCELA and can lead to death. Rituximab products can increase the risk of getting infections and can lower the ability of the immune system to fight infections. Types of serious infections that can happen with RITUXAN HYCELA include bacterial, fungal, and viral infections. After receiving RITUXAN HYCELA, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these people with low antibody levels developed infections. Patients must tell their healthcare provider right away if they have any symptoms of infection: fever; cold symptoms, such as runny nose or sore throat that do not go away; flu symptoms, such as cough, tiredness, and body aches; earache or headache; pain during urination; white patches in the mouth or throat; cuts, scrapes, or incisions that are red, warm, swollen, or painful.
• Heart Problems: RITUXAN HYCELA may cause chest pain, irregular heartbeats, and heart attack. The patient’s healthcare provider may monitor the patient’s heart during and after treatment with RITUXAN HYCELA if they have symptoms of heart problems or have a history of heart problems. Patients must tell their healthcare provider right away if they have chest pain or irregular heartbeats during treatment with RITUXAN HYCELA.
• Kidney Problems: RITUXAN HYCELA can cause severe kidney problems that can lead to death. The patient’s healthcare provider should do blood tests to check how well the patient’s kidneys are working.
• Stomach and serious bowel problems that can sometimes lead to death: Bowel problems, including blockage or tears in the bowel, can happen if the patient receives RITUXAN HYCELA with chemotherapy medicines. Patients must tell their healthcare provider right away if they have severe stomach-area (abdomen) pain or repeated vomiting during treatment with RITUXAN HYCELA.

The patient’s healthcare provider will stop treatment with RITUXAN HYCELA if the patient has severe, serious, or life-threatening side effects.

The most common side effects of RITUXAN HYCELA in people with:

• FL: infections, low white blood cell count, nausea, constipation, cough, and tiredness.
• DLBCL: infections, low white blood cell count, loss of hair, nausea, and low red blood cell count.
• CLL: infections, low white blood cell count, nausea, low platelet count, fever, vomiting, and injection site redness.

Additional Important Safety Information

Before receiving RITUXAN HYCELA, patients must tell their healthcare provider about all of their medical conditions, including if they:

• Have had a severe reaction to a rituximab product or RITUXAN HYCELA.
• Have had a recent vaccination or are scheduled to receive vaccinations. Patients should not receive certain vaccines before or during treatment with RITUXAN HYCELA.
• Are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. Patients should talk to their healthcare provider about the risks to their unborn baby if they receive RITUXAN HYCELA during pregnancy. Females who are able to become pregnant should use effective birth control (contraception) during treatment with RITUXAN HYCELA and for 12 months after the last dose of RITUXAN HYCELA. Patients should talk to their healthcare provider about effective birth control. It is not known if RITUXAN HYCELA passes into the patient’s breast milk. Patients must not breastfeed during treatment and for at least 6 months after receiving their last dose of RITUXAN HYCELA.

These are not all of the possible side effects with RITUXAN HYCELA. Patients should call their doctor for medical advice about side effects.

Please see the full Prescribing Information, including BOXED WARNINGS and Medication Guide, for additional Important Safety Information.

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.

Rituxan Indications

Rituxan^® (rituximab) injection, for intravenous use, is indicated for the treatment of patients with:

• Low-grade or follicular CD20-positive non-Hodgkin’s lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
• Follicular CD20-positive non-Hodgkin’s lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
• Low-grade CD20-positive non-Hodgkin’s lymphoma as a single-agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
• CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma as an initial treatment in combination with CHOP chemotherapy
• CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred

People with serious infections should not receive Rituxan.

It is not known if Rituxan is safe or effective in children.  

Important Safety Information:

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:

• 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. Patients 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.

Other side effects with Rituxan include:

• aching joints during or within hours of receiving an infusion
• more frequent upper respiratory tract infection

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.

Please see the Rituxan full Prescribing Information, including BOXED WARNINGS and the Medication Guide, for additional Important Safety Information at http://www.Rituxan.com.

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.

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. In addition to approved medicines, Genentech’s pipeline of investigational hematology medicines includes an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). Genentech’s dedication to developing novel medicines for blood diseases expands beyond oncology, with the development of the investigational hemophilia A treatment emicizumab. For more information visit http://www.gene.com/hematology .

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 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.

###