publication date: Mar. 1, 2019

Drugs & Targets

FDA approves new formulation of Herceptin

FDA has approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use. Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.

Herceptin Hylecta is sponsored by Genentech Inc., a unit of Roche.

The approval was based on two randomized trials, HannaH (NCT00950300) and SafeHER (NCT01566721). In HannaH, 596 patients with HER2-positive operable or locally advanced breast cancer, including inflammatory breast cancer, were randomized to receive 8 cycles of either Herceptin Hylecta or intravenous trastuzumab concurrently with chemotherapy, followed by surgery and continued therapy with either Herceptin Hylecta or intravenous trastuzumab, for an additional 10 cycles.

HannaH demonstrated comparability between Herceptin Hylecta and intravenous trastuzumab based on co-primary endpoints of pathologic complete response and pharmacokinetics. Pathological complete response was observed in 118 patients (45.4%) on the Herceptin Hylecta arm and in 107 patients (40.7%) receiving intravenous trastuzumab (95% CI for difference in pCR: -4.0; 13.4).

SafeHER was a prospective, two-cohort, non-randomized, multinational, open-label trial assessing the overall safety and tolerability of Herceptin Hylecta with chemotherapy in 1,864 patients with HER2-positive breast cancer.

Patients received a fixed dose of 600 mg Herceptin Hylecta every 3 weeks for 18 cycles. Herceptin Hylecta was initiated either sequentially with chemotherapy, concurrently with chemotherapy, or without adjuvant chemotherapy, or in combination with neoadjuvant chemotherapy followed by trastuzumab.

The recommended Herceptin Hylecta dose is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately 2-5 minutes once every three weeks.


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FDA has approved … Continue reading FDA approves new formulation of Herceptin

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