Herceptin® Subcutaneous Injection Approved in China, Offering a Faster and More Convenient Treatment Option for HER2-Positive Breast Cancer Patients

Roche Pharmaceuticals announced that on October 9, 2022, the China National Medical Products Administration (NMPA) officially approved Herceptin® (Generic name: Trastuzumab Injection [Subcutaneous Injection]), in combination with chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer patients.

As the world's first innovative targeted drug for HER2-positive breast cancer, trastuzumab is the cornerstone of HER2-positive breast cancer treatment. The new subcutaneous injectable formulation of trastuzumab revolutionizes the treatment model for HER2-positive breast cancer, offering Chinese breast cancer patients a more convenient, efficient, and safer personalized treatment option.

20-Year Classic Breakthrough: Decoding the Most Dangerous HER2 Curse

Breast cancer is the most common type of cancer among women, with over 2 million new cases diagnosed globally each year. In 2020, there were approximately 420,000 new cases in China. HER2-positive breast cancer is a particularly aggressive subtype, accounting for about 15-20% of breast cancer cases. It is characterized by high malignancy, a high recurrence and metastasis rate, a tendency for lymph node metastasis, and a generally poor prognosis.

Since the introduction of Roche's original biologic Herceptin® (generic name: Trastuzumab Injection), the anti-HER2 treatment regimen based on it has become the "gold standard" and "cornerstone" for the entire treatment process in the field of HER2-positive breast cancer. Over the past 20 years, it has significantly improved long-term survival benefits for patients with HER2-positive breast cancer from early to advanced stages.

"Subcutaneous Injection" Formulation Significantly Improves Patient Treatment Experience

Breast cancer patients undergoing anti-HER2 therapy require a longer treatment course. Currently, the traditional intravenous infusion formulation necessitates hospital visits every three weeks, with each administration lasting 30 to 90 minutes. Repeated venous trauma not only causes harm to patients but also brings inconvenience to their daily lives due to prolonged intravenous infusions.

Herceptin® Subcutaneous Formulation Will Bring Great Convenience to Patient Treatment, Making Outpatient Breast Cancer Treatment Possible.

The advantage of subcutaneous injection is that the hyaluronidase in the formulation can temporarily reduce the viscosity of the intercellular matrix, promoting the rapid diffusion and absorption of trastuzumab, thus making it a ready-to-use formulation that can be completed in just 2 to 5 minutes. At the same time, compared with intravenous injection, the subcutaneous formulation has a fixed dose, which means there is no need to calculate the dose based on each patient's weight every time, greatly facilitating both patients and medical staff. This is a particularly important advantage, especially in pandemic-controlled areas, minimizing the impact of cancer treatment on quality of life. It can be said that the subcutaneous injection formulation optimizes the overall management pattern of breast cancer treatment.

Multiple global studies validate safety and efficacy, more popular among patients and healthcare professionals

According to the results of multiple international clinical studies: The efficacy and safety of subcutaneous trastuzumab are comparable to standard intravenous trastuzumab. The new formulation not only reduces treatment costs and significantly saves treatment time but also offers greater convenience for breast cancer patients.

Phase III HannaH Study Compared the Efficacy of Subcutaneous Injection of Herceptin® Combined with Chemotherapy Versus Intravenous Injection of Herceptin® Combined with Chemotherapy as Neoadjuvant Treatment (Pre-surgery) or Adjuvant Treatment (Post-surgery) in Patients with HER2-positive Breast Cancer. The Results Showed that the Blood Levels of Trastuzumab (Pharmacokinetic Characteristics) and Clinical Efficacy "Pathological Complete Response Rate, pCR (45.4% vs. 40.7%)" in Patients Receiving Subcutaneous Injection Were Non-inferior to Those Receiving Intravenous Injection, with Similar Safety Profiles. Data from Asian patients were Consistent with the Global Population [1].

Phase III SafeHER study investigated the safety and tolerability of subcutaneous formulation of Herceptin®. The results showed that the safety and tolerability of the new formulation were consistent with previously reported safety profiles, with no new safety signals identified. No new safety signals were found in Asian patients [2].

The PrefHER study investigated patient preferences for medication administration, and the results showed that the majority of patients (86%) preferred Herceptin® subcutaneous injection treatment. The subcutaneous formulation was also more popular among healthcare professionals, with 77% of doctors and nurses surveyed expressing a preference for the subcutaneous formulation [3].

References:

[1] Ismael G, et al. Lancet Oncol 2012

[2] Jung KH et al. ESMO 2016 (Poster 211P)

[3] Pivot X, et al. Ann Oncol 2014

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