Trastuzumab subcutaneous preparation approved in China for administration in only 2-5 minutes!

On October 9, 2022, Roche Pharma China announced that HER2-positive breast cancer targeted therapy drug Herceptin ^® subcutaneous preparation (English trade name: Herceptin^® SC, Chinese and English generic name: trastuzumab injection (subcutaneous injection) / Trastuzumab Injection [Subcutaneous Injection] Officially approved by the State Drug Administration of China (NMPA) for HER2-positive early and metastatic breast cancer

The subcutaneous preparation is simple and convenient, benefiting patients and medical staff in all aspects

Breast cancer is the most common cancer in the world, with about 2.

Trastuzumab injection (subcutaneous) is a 2-in-1 fixed-dose ready-to-use subcutaneous injection preparation of trastuzumab and recombinant human hyaluronidase (rHuPH20

Trastuzumab subcutaneous preparations offer many advantages over intravenous preparations:

1) The subcutaneous preparation is a fixed dose, and there is no need for dose calculation and configuration, which can greatly reduce the risk of dose errors, reduce drug waste, and reduce the workload of

2) The shorter subcutaneous administration time (2-5 minutes) and observation period (15 minutes) can reduce the burden on patients, caregivers and doctors, and relieve the pressure

3) The trauma of subcutaneous administration is smaller, there is no need for indwelling intravenous infusion channels, higher safety, reducing the pain and discomfort of intravenous infusion during administration, improving the patient's treatment experience, and reducing the risk

4) The way of subcutaneous administration is simpler and more convenient, and no additional intravenous infusion facilities are required, which can improve the patient's medical experience, alleviate the pressure of hospitalization, improve the efficiency of hospital operations, and save medical resources

Subcutaneous preparations are safe and effective and better meet clinical needs

The efficacy and safety of trastuzumab subcutaneous preparations, as well as patient selection preferences, were confirmed in 3 key clinical studies in patients with HER2-positive breast cancer:

1) Phase III HannaH study ² compared the efficacy

2) Phase III SafeHER Study ³ investigated the use of trastuzumab subcutaneous preparations for adjuvant therapy, and the results showed that the safety and tolerance of subcutaneous preparations were consistent with the previous safety characteristics of trastuzumab intravenous preparations, and no new safety signals

3) PrefHER study ⁴ investigated patient preference and showed that most patients (86%) preferred trastuzumab subcutaneous preparations, and only 13% preferred to receive intravenous trastuzumab preparations

In summary, it can be seen that the efficacy and safety of trastuzumab subcutaneous preparations are comparable to those of intravenous trastuzumab, and because the administration time is greatly shortened, trastuzumab subcutaneous preparations better meet the needs of

In April 2021, the NMPA Center for Drug Evaluation (CDE) accepted an application for

It is worth mentioning that Roche Pharma China also disclosed that on July 27 this year, the domestic marketing application of Roche pertuzumab trastuzumab injection (subcutaneous injection) was accepted, which is a fixed-dose combination of subcutaneous preparations (trade name Phesgo^®), which has previously been approved in the United States, the European Union and other countries and regions for the treatment of early and metastatic HER2-positive breast cancer patients

About breast cancer

Breast cancer is the most common type of cancer in women, with more than 2 million cases confirmed worldwide each year, and about 420,000 new cases in China in 2020

About Herceptin^®

Herceptin ^® is a recombinant DNA-derived humanized monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2) and specifically acts on the outer cell site

References:

1.

2.
Jackisch C, et al.
HannaH phase III randomised study: Association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up.
Eur J Cancer.
2016 Jul; 62:62-75.

3.
Gligorov J, et al.
Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients.
Eur J Cancer.
2017 Sep; 82:237-246.

4.
Pivot X, et al.
Abstract P4-12-11: Patient preference for subcutaneous trastuzumab via handheld syringe versus intravenous infusion in HER2-positive early breast cancer: Cohort 2 of the PrefHer study.
SABCS 2013.
Abstract P4-12-11.