Company Roche announced that the FDA food and drug administration (FDA) approved a fixed combination of the drugs pertuzumab and trastuzumab with hyaluronidase for subcutaneous injection (p/C), in combination with intravenous (IV) chemotherapy in patients with early and metastatic HER2-positive breast cancer. Was first eaten two monoclonal antibodies, which can introduce a single subcutaneous injection.
A new drug is available in single-dose vials. The introduction of the initial loading dose may take about eight minutes, the introduction of each subsequent maintenance dose is approximately five minutes. For a consistent introduction of a loading dose of the drugs pertuzumab and trastuzumab with standard IV infusion takes about 150 minutes for the introduction of subsequent maintenance doses of from 60 to 150 minutes. Combination drug may be administered by a medical professional in terms of hospitals or in the patient’s home.
The basis of the registration application went results clinical studies phase III FeDeriCa, in which the drug showed the same level of concentration, pertuzumab in the blood during a given dosing interval when administered intravenously. The safety profile of a new drug in combination with chemotherapy were similar to those for using injectable forms of the drugs pertuzumab and trastuzumab; did not identify new safety signals, including no significant differences in toxic effects on the heart. The most common adverse events in both cases were alopecia, nausea, diarrhea and anemia.
In the phase II study PHranceSCa 85% of patients (136 of 160), receiving treatment for HER2-positive breast cancer, preferred subcutaneous administration intravenously, because it reduces the time of stay in the hospital and provides a more comfortable healing process.