Roche's Subcutaneous Trastuzumab Injection (Herceptin Hylecta®) New Drug Application Accepted by China's CDE

On April 21, the Center for Drug Evaluation (CDE) accepted Roche’s marketing application for trastuzumab injection (subcutaneous), indicating that this subcutaneous formulation will soon become accessible in China.

Subcutaneous trastuzumab is a fixed-dose combination of trastuzumab and recombinant human hyaluronidase, approved by the FDA in February 2019 for the treatment of adult patients with HER2-overexpressing metastatic breast cancer; brand name: Herceptin Hylecta.^®。

The U.S. FDA Approved Herceptin Hylecta Based on the Results of the Following Clinical Trials^®Listing:

1) In the phase III HannaH study, neoadjuvant and adjuvant therapy with Herceptin Hylecta® plus chemotherapy versus intravenous Herceptin^®+ chemotherapy. The results showed that subcutaneous Herceptin Hylecta® was non-inferior to intravenous Herceptin® in terms of pharmacokinetics and clinical efficacy.

2) The second study, SafeHER, was a prospective, dual-cohort, non-randomized, international, open-label trial in which researchers evaluated the safety and tolerability of Herceptin Hylecta combined with chemotherapy in 1,864 patients with HER2-positive breast cancer. The results demonstrated that the safety profile of the new formulation was consistent with that of the previously established standard formulation of trastuzumab.

3) The third study, PrefHER, was a patient preference trial in which 240 patients received adjuvant Herceptin Hylecta followed by intravenous trastuzumab, or the reverse sequence. The results showed that 86% of the trial patients preferred the subcutaneous regimen.

Herceptin Hylecta, as a ready-to-use formulation, can be administered within 2–5 minutes, whereas intravenous infusion of Herceptin requires 30–90 minutes, significantly reducing the time required for administration. Following its market launch in China, Herceptin Hylecta will provide physicians and patients with a new therapeutic option, allowing treatment plans to be selected based on individual needs and preferences.