Tecentriq Hybreza FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 29, 2024.

FDA Approved: Yes (First approved September 12, 2024)
Brand name: Tecentriq Hybreza
Generic name: atezolizumab and hyaluronidase-tqjs
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Non Small Cell Lung Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma, Melanoma, Alveolar Soft Part Sarcoma

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) is a programmed death-ligand 1 (PD-L1) blocking antibody and endoglycosidase combination used for the treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.

• Tecentriq Hybreza is indicated for:
  Non-Small Cell Lung Cancer (NSCLC)
  • as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.
  • for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDAapproved test, with no EGFR or ALK genomic tumor aberrations.
  • in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
  • in combination with paclitaxel protein-bound and carboplatin for the firstline treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
  • for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq Hybreza.
  Small Cell Lung Cancer (SCLC)
  • in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
  Hepatocellular Carcinoma (HCC)
  • in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy.
  Melanoma
  • in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as determined by an FDA-approved test.
  Alveolar Soft Part Sarcoma (ASPS)
  • for the treatment of adult patients with unresectable or metastatic ASPS.
• Tecentriq (atezolizumab) was first approved in 2016 as an injection formulation for administration by intravenous (IV) infusion. Tecentriq Hybreza is a new injection formulation containing hyaluronidase-tqjs that is administered subcutaneously over a period of approximately 7 minutes, compared with 30-60 minutes for the standard IV infusion of Tecentriq.
• Tecentriq (atezolizumab) is a monoclonal antibody that works in the treatment of certain cancers by binding with PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, and blocking its interactions with both PD-1 and B7.1 receptors to activate the anti-tumor immune response. Tecentriq Hybreza combines Tecentriq with the Enhanze^® drug delivery technology, which is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream.
• FDA approval of Tecentriq Hybreza was based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. Data from the Phase II IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab.
• Warnings and precautions associated with Tecentriq Hybreza include immune-mediated adverse reactions, infusion-related reactions, serious complications in patients who receiving allogeneic HSCT, and embryo-fetal toxicity.
• Common adverse reactions:
  - in patients with NSCLC receiving Tecentriq Hybreza (monotherapy) include fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
  - in patients with first-line NSCLC receiving intravenous atezolizumab* (monotherapy) include fatigue/asthenia.
  - in patients with metastatic NSCLC receiving intravenous atezolizumab* (monotherapy) include fatigue/asthenia, cough, decreased appetite, dyspnea, and myalgia/pain.
  - in patients with ASPS receiving intravenous atezolizumab* (monotherapy) include musculoskeletal pain, fatigue, rash, cough, headache, nausea, hypertension, vomiting, constipation, dyspnea, dizziness, hemorrhage, diarrhea, insomnia, abdominal pain hypothyroidism, pyrexia, anxiety, arrhythmia and decreased appetite.
  - in patients with NSCLC receiving intravenous atezolizumab* in combination with bevacizumab, paclitaxel, and carboplatin include neuropathy fatigue/asthenia, alopecia, myalgia, nausea, diarrhea, constipation, decreased appetite, arthralgia, hypertension, rash, cough.
  - in patients with non-squamous NSCLC receiving intravenous atezolizumab* in combination with paclitaxel protein-bound and carboplatin include fatigue/asthenia, nausea, diarrhea, myalgia/pain, constipation, neuropathy, alopecia, dyspnea, decreased appetite, cough, vomiting and rash.
  - in patients with SCLC receiving intravenous atezolizumab* in combination with carboplatin and etoposide include fatigue/asthenia, nausea, alopecia, decreased appetite, constipation and vomiting.
  - in patients with HCC receiving intravenous atezolizumab* in combination with bevacizumab include hypertension, fatigue and proteinuria.
  - in patients with melanoma receiving intravenous atezolizumab* in combination with cobimetinib and vemurafenib include rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction.
  * _{the safety of Tecentriq Hybreza for the approved NSCLC, SCLC, HCC, melanoma and ASPS indications is based on safety of intravenous atezolizumab in these populations.}

Development timeline for Tecentriq Hybreza

Further information

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