FDA Approves New Formulation of Trastuzumab for Subcutaneous Use in Some Breast Cancers
Posted: Thursday, March 7, 2019
On February 28, the U.S. Food and Drug Administration (FDA) approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) for subcutaneous use in the treatment of certain patients with HER2-positive early breast cancer (node-positive, node-negative and estrogen receptor/progesterone receptor–negative, or with one high-risk feature) in combination with chemotherapy. The FDA also approved the treatment in patients with HER2-positive metastatic breast cancer in combination with paclitaxel or alone in patients who have received one or more prior chemotherapy regimens for metastatic disease.
This new formulation includes the same monoclonal antibody as intravenous trastuzumab in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab subcutaneously. The trastuzumab and hyaluronidase-oysk combination is a ready-to-use formulation that can be administered in 2 to 5 minutes, compared with 30 to 90 minutes for intravenous trastuzumab. Patients should be selected for therapy with the combination based on an FDA-approved companion diagnostic for trastuzumab.
The FDA approval is based on results from three clinical studies in HER2-positive early breast cancer:
- The phase III HannaH study (ClinicalTrials.gov identifier NCT00950300) compared neoadjuvant and adjuvant trastuzumab/hyaluronidase-oysk with intravenous trastuzumab, both in combination with chemotherapy. The pathologic complete response rate was 45.4% with trastuzumab/hyaluronidase-oysk versus 40.7% with trastuzumab alone.
- The phase III SafeHER study (NCT01566721) of adjuvant trastuzumab/hyaluronidase-oysk identified no new safety signals, with safety and tolerability consistent with the known safety profiles of intravenous trastuzumanb and trastuzumab/hyaluronidase-oysk.
- The PrefHER patient preference study (NCT01401166) of adjuvant trastuzumab/hyaluronidase-oysk followed by intravenous trastuzumab, or the reverse sequence, found the majority (86%) of patients preferred trastuzumab/hyaluronidase-oysk over intravenous trastuzumab.
The most common side effects in people receiving trastuzumab/hyaluronidase-oysk for early breast cancer were fatigue, joint pain, diarrhea, injection-site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and extremity pain.