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HERCEPTIN (trastuzumab), which is the first antibody product approved in the United States for the treatment of a solid tumor, was approved in September 1998 for the treatment of metastatic breast cancer. Since this approval, there has been a great deal of progress and advancements in monoclonal antibody (mAb) development. Today, more than 75 mAbs and mAb derivatives, including fusion proteins and mAB fragments, are available for the treatment of a variety of indications.
Intravenous (IV) infusion of HERCEPTIN is a well-established treatment modality. Development and approval of subcutaneous (SC) administration, however, has overcome a number of limitations related to IV infusion. Being less invasive and with an injection duration of approximately 5 minutes, SC dosing is more convenient for patients compared to IV infusion, which takes about 30–90 minutes depending on the treatment cycle and individual tolerability. While IV infusion is typically administered in a hospital or physician’s office, SC administration may allow health care professional-assisted home/patient self-administration in an outpatient setting.
To achieve a dosing volume suitable for SC injection, Herceptin IV formulation was concentrated from approximately 21 to 120 mg/mL, and was further formulated with recombinant human hyaluronidase (rHuPH20), an enzyme that temporarily degrades hyaluronan in the interstitial space, thereby facilitating the spreading of injected volumes over a greater area.
Since its first approval in the EU in 2013, HERCEPTIN SC has now been approved in over 80 countries worldwide, and was also US FDA approved recently.
In 2020, a coformulation SC of trastuzumab and pertuzumab (PHESGO) has been approved by the FDA. There are other SC programs such as atezolizumab, mosunetuzumab.
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