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FDA Recently Approved Trazimera & Herceptin Hylecta

Trazimera™ (trastuzumab-qyyp), an engineered biologic medication that is a “biosimilar” to Herceptin, was recently approved by the U.S. Food & Drug Administration (FDA). Trazimera was approved for use in patients with HER2+ breast cancer, as well as HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma. HER2+ breast cancer is characterized by tumors that overproduce a specific molecule known as human epidermal growth factor receptor-2, or HER2.1

Trazimera can be used against metastatic breast cancer or as adjuvant therapy.2 Metastatic breast cancer refers to advanced breast cancer that has already spread to other parts of the body. Adjuvant therapy is given after initial treatment, like surgery, with the goal of reducing the risk of recurrence.2

What is Trazimera and how does it work?

Trazimera is a monoclonal antibody, which is a type of targeted therapy. Certain breast cancer cells have large numbers of molecules called human epidermal growth factor receptor-2, or HER2, on their cell surfaces. Trazimera, like Herceptin, targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow. Trazimera locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.1,3

What is a biosimilar?

A biosimilar is a product that is highly similar to an already approved product. Biosimilars are not the same as generics, which have the same active ingredient and are equivalent copies of a reference medicine. However, biosimilars must undergo a thorough evaluation to ensure their safety and effectiveness before they receive approval, demonstrating no clinically meaningful differences from the approved reference product. Biosimilar medications are approved based on the similarity of their action to approved medications.4

More Herceptin news

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk), also received recent approved by the U.S. Food & Drug Administration. Herceptin Hylecta™ is also a targeted treatment used to treat breast cancer that is positive for the human epidermal growth factor receptor 2 (HER2+).5,6 This new treatment includes the same monoclonal antibody as intravenous Herceptin® (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab subcutaneously (which means delivered under the skin).7 Herceptin Hylecta is a ready-to-use formulation that can be administered much more quickly than intravenous Herceptin, reducing administration time to 2 to 5 minutes, compared to 30 to 90 minutes for the intravenous formulation. This new formulation has been approved for certain individuals with early stage breast cancer and certain individuals with metastatic breast cancer.6

Alternative option

The Chief Medical Officer and Head of Global Product Development for Roche, Sandra Horning, MD, spoke to the importance of this new formulation, “Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer.” “The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences.”6

  1. Pfizer. U.S. FDA Approves Pfizer’s Oncology Biosimilar TRAZIMERA™ (trastuzumab-qyyp), a Biosimilar to Herceptin. https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_oncology_biosimilar_trazimera_trastuzumab_qyyp_a_biosimilar_to_herceptin_1. Accessed March 14, 2019.
  2. Adjuvant therapy: Treatment to keep cancer from returning. Mayo Clinic. Updated November 3, 2018. Available at: https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/adjuvant-therapy/art-20046687. Accessed March 14, 2019.
  3. FDA Prescribing Information TRAZIMERA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf. Accessed March 14, 2019.
  4. Biosimilar and Interchangeable Products. U.S. Food & Drug Administration. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm. Accessed March 14, 2019.
  5. US Food and Drug Administration. FDA Approves Hylecta, a New Formulation of Herceptin for Subcutaneous Use. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm632294.htm. Accessed March 14, 2019
  6. Genentech. FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers. https://www.gene.com/media/press-releases/14779/2019-02-28/fda-approves-herceptin-hylecta-for-subcu. Accessed March 14, 2019
  7. Herceptin Hylecta Prescribing Information https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761106s000lbl.pdf. Accessed March 14, 2019

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