On April 21, Roche's application for the marketing of trastuzumab injection (subcutaneous injection) was accepted by CDE, which means that this subcutaneous preparation will soon be available in China.
The subcutaneously injected trastuzumab is a compound preparation composed of trastuzumab and recombinant human hyaluronidase.
It was approved by the FDA in February 2019 for the treatment of adult metastatic breasts with HER2 overexpression Cancer, trade name: Herceptin Hylecta®.
The US FDA approved the marketing of Herceptin Hylecta® based on the results of the following clinical trials:
1) In a phase III HannaH study, neoadjuvant therapy and adjuvant therapy using Herceptin Hylecta® + chemotherapy were compared with intravenous Herceptin® + chemotherapy.
The results showed that, compared with intravenous Herceptin®, subcutaneous injection of Herceptin Hylecta® achieved non-inferiority in both pharmacokinetics and clinical efficacy.
2) The second study, SafeHER, is a prospective, two-cohort, non-randomized, international, open-label trial.
Researchers evaluated the safety and tolerability of Herceptin Hylecta combined chemotherapy in 1864 HER2-positive breast cancer patients .
The results of the study show that the safety of the new dosage form is consistent with the previous standard dosage form of trastuzumab.
3) The third study, PrefHER, is a patient preference trial.
240 patients received adjuvant Herceptin Hylecta treatment followed by intravenous trastuzumab treatment, or in the reverse order.
The results showed that 86% of trial patients preferred the subcutaneous regimen.
As a ready-to-use preparation, Herceptin Hylecta can be administered within 2-5 minutes, while the time required for intravenous infusion of Herceptin is 30-90 minutes, which greatly shortens the administration process.
After Herceptin Hylecta goes on the market in China, it will provide doctors and patients with a new choice to choose a treatment plan according to individual needs and preferences.