Tecentriq Hybreza

Tecentriq Hybreza is used to treat adults with non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (SCLC), hepatocellular carcinoma, melanoma, or muscle invasive bladder cancer (MIBC), and adults and children aged 12 years and older who weigh 40 kg (88 pounds) or more with alveolar soft part sarcoma (ASPS) or stage III mismatch repair deficient (dMMR) colon cancer. It is an immunotherapy treatment given by subcutaneous injection and used alone or in combination with other medicines, depending on the cancer type and stage.

Tumors can produce a protein called PD-L1 that suppresses the immune system's ability to attack cancer cells. The atezolizumab in Tecentriq Hybreza works by binding to PD-L1 and blocking its interaction with the PD-1 and B7.1 receptors on immune cells, which releases this brake on the immune response against the tumor. In studies in mice, blocking PD-L1 reduced tumor growth, and combining PD-L1 blockade with targeted therapy that blocks the MAPK pathway suppressed tumor growth more than the targeted therapy alone. Atezolizumab belongs to the drug class called PD-L1 blocking antibodies. It is also called an immune checkpoint inhibitor or monoclonal antibody.

Tecentriq Hybreza also contains hyaluronidase-tqjs, an enzyme that temporarily increases the permeability of the tissue under the skin so that the 15 mL dose can be injected into the thigh over approximately 7 minutes by a healthcare professional. Intravenous Tecentriq is given as an infusion over 30 to 60 minutes.

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) first received FDA approval on September 12, 2024. There is no generic.

Tecentriq Hybreza (atezolizumab and hyaluronidase) is a PD-L1 inhibitor FDA-approved to treat:

• Non-small cell lung cancer (NSCLC) in adults, as: Adjuvant treatment: After surgery and platinum-based chemotherapy in adults with Stage II–IIIA NSCLC whose tumors express PD-L1 on ≥1% of tumor cells (FDA-authorized test required). First-line monotherapy: For metastatic NSCLC with high PD-L1 expression (TC ≥50% or IC ≥10%), and no EGFR or ALK aberrations (FDA-authorized test required). First-line combination therapy: With bevacizumab, paclitaxel, and carboplatin; or with paclitaxel protein-bound and carboplatin; for metastatic non-squamous NSCLC with no EGFR or ALK aberrations. Previously treated metastatic NSCLC: For adults with disease progression during or after platinum-based chemotherapy. Patients with EGFR or ALK aberrations must have progressed on an FDA-approved targeted therapy before receiving Tecentriq Hybreza.
• Extensive-stage small cell lung cancer (ES-SCLC) in adults, as: First-line treatment: In combination with carboplatin and etoposide. Maintenance treatment: In combination with lurbinectedin for adults with ES-SCLC whose disease has not progressed following first-line induction therapy with Tecentriq Hybreza or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.
• Hepatocellular carcinoma (HCC) in adults, as: First-line treatment: In combination with bevacizumab for adults with unresectable or metastatic HCC who have not previously received systemic therapy.
• Melanoma in combination with cobimetinib and vemurafenib for adults with unresectable or metastatic melanoma that carries a BRAF V600 mutation.
• Alveolar Soft Part Sarcoma (ASPS) in adults and children 12 years of age and older who weigh 40 kg or greater with unresectable or metastatic ASPS
• Muscle invasive bladder cancer (MIBC) as: Adjuvant treatment: Following cystectomy in adults with confirmed molecular residual disease, indicated by circulating tumor DNA (ctDNA) detected via an FDA-authorized test.
• Mismatch repair deficient (dMMR) colon cancer in adults and children 12 years of age and older who weigh 40 kg or more, as: Adjuvant treatment: In combination with a fluoropyrimidine and oxaliplatin for stage III dMMR colon cancer. Patients are selected based on dMMR status in tumor specimens. An FDA-authorized test for dMMR tumor status is not currently available.

It is not known if Tecentriq Hybreza is safe and effective in children younger than 12 years of age for the treatment of ASPS or colon cancer, or in children for the treatment of NSCLC, SCLC, HCC, melanoma, or MIBC.

Your healthcare provider will give you Tecentriq Hybreza as an injection under the skin in the thigh over about 7 minutes. Tecentriq Hybreza is given every 3 weeks. Your healthcare provider will decide how many treatments you need. Your healthcare provider will test your blood to check for certain side effects. For the treatment of a type of skin cancer called melanoma, your healthcare provider will also prescribe you cobimetinib and vemurafenib. Take cobimetinib and vemurafenib exactly as your healthcare provider tells you.

• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment

Tecentriq Hybreza is a medicine that may treat certain cancers by working with your immune system. Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

• Lung problems with symptoms such as: cough shortness of breath chest pain.
• Intestinal problems. Symptoms include: diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness.
• Liver problems, with symptoms such as: yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal.
• Kidney problems. Symptoms may include: decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite.
• Hormone gland problems. Symptoms may include: headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
• Skin problems, such as: rash itching skin blistering or peeling painful sores or ulcers in your mouth or your nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes.

Problems can also happen in other organs. These are not all of the signs and symptoms of the immune system problems that can happen with Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including:

• chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising.

Infusion reactions can occur that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feeling like passing out
• fever
• back or neck pain.

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq Hybreza. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroids or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq Hybreza if you have severe side effects.

Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza.

Before receiving Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you:

• Have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• Have received an organ transplant or tissue transplant, including corneal transplant
• Have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• Have received radiation treatment to the chest area
• Have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

Tecentriq Hybreza can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq Hybreza. Females who can become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq Hybreza.
• You should use an effective method of birth control during your treatment and for 5 months after the last dose of Tecentriq Hybreza.

Breastfeeding

It is not known if Tecentriq Hybreza passes into your breast milk. Do not breastfeed during treatment and for 5 months after the last dose of Tecentriq Hybreza.

Tecentriq Hybreza can cause serious side effects. See Important Information above.

Common Side Effects

The most common side effects of Tecentriq Hybreza when used alone in NSCLC include:

• Feeling tired or weak
• Muscle or bone pain
• Cough
• Shortness of breath
• Decreased appetite.

The most common side effects observed with intravenous Tecentriq, which may be experienced with Tecentriq Hybreza, are shown below.

Abbreviations: NSCLC = non-small cell lung cancer | SCLC = small cell lung cancer | HCC = hepatocellular carcinoma | ASPS = alveolar soft part sarcoma | MIBC = muscle-invasive bladder cancer | dMMR = mismatch repair deficient

Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq Hybreza. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The recommended dosage and administration of Tecentriq Hybreza differs from that of intravenous Tecentriq infusion. It must be administered by a healthcare professional.

• Tecentriq Hybreza is for subcutaneous use in the thigh only. Do not administer it intravenously.

The recommended dosage for adults and for children 12 years of age and older who weigh 40 kg or more is 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks. The dosage for children 12 years and older who weigh less than 40 kg has not been established.

Dose of Tecentriq Hybreza for Non-Small Cell Lung Cancer (NSCLC)

• Following resection and up to 4 cycles of platinum-based chemotherapy: 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks for up to 1 year.
• In the metastatic setting: 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks.
• When administering with chemotherapy with or without bevacizumab, administer Tecentriq Hybreza before chemotherapy and bevacizumab when given on the same day

Dose of Tecentriq Hybreza for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

• 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks.
• Administer before chemotherapy when given on the same day.

Dose of Tecentriq Hybreza for Hepatocellular Carcinoma (HCC)

• 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks.
• Administer before bevacizumab when given on the same day.

Dose of Tecentriq Hybreza for Melanoma

• Following completion of a 28-day cycle of cobimetinib and vemurafenib, administer 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily.

Dose of Tecentriq Hybreza for Alveolar Soft Part Sarcoma (ASPS)

• Adults and pediatric patients 12 years and older: 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks.

Dose of Tecentriq Hybreza for Muscle Invasive Bladder Cancer (MIBC)

• Adults and pediatric patients 12 years of age and older who weigh 40 kg or more: 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks.
• Administer Tecentriq Hybreza after cystectomy at 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks for up to 1 year.

Dose of Tecentriq Hybreza for mismatch repair deficient (dMMR) colon cancer

• Adults and pediatric patients 12 years of age and older who weigh 40 kg or more: 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over approximately 7 minutes every 3 weeks.
• Give Tecentriq Hybreza in combination with chemotherapy for 6 months, followed by Tecentriq Hybreza as monotherapy for 6 months or until disease recurrence or unacceptable toxicity.
• If chemotherapy is discontinued early, total Tecentriq Hybreza treatment should not exceed 12 months.
• Administer Tecentriq Hybreza before chemotherapy when given on the same day.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Other drugs may interact with Tecentriq Hybreza, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Active ingredient: atezolizumab and hyaluronidase-tqjs

Inactive ingredients: acetic acid, histidine, methionine, polysorbate 20, sucrose, water for injection.

Tecentriq Hybreza is manufactured by Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 USA, and Halozyme, Inc., 12390 El Camino Real, San Diego, CA 92130 USA.