HER2 + breast cancer innovation! The combination of perjeta and Herceptin subcutaneous preparation of Roche fixed dose was accepted by FDA in the United States, and the administration only took 5-8 minutes

February 26, 2020 / BIOON / -- Roche recently announced that the U.S Food and Drug Administration (FDA) has accepted a biological product licensing application (BLA) submitted by it, which seeks to approve the subcutaneous preparation of perjeta and Herceptin fixed dose combination (FDC), combined with intravenous chemotherapy for the treatment of eligible HER2 positive breast cancer patients This FDC subcutaneous preparation is developed by enhanze drug delivery technology of halozyme company The technology is based on a proprietary recombinant human hyaluronidase PH20 (rhuph20), which can temporarily degrade the hyaluronic acid in the body, help the injection drugs disperse and absorb faster, and realize the subcutaneous injection Compared with intravenous administration, this fixed dose combined subcutaneous administration can be completed in a few minutes, which can significantly shorten the time of patients receiving treatment Specifically, this fixed dose combination (FDC) perjeta + Herceptin subcutaneous preparation was administered by subcutaneous injection (SC) The initial loading dose took about 8 minutes, and the subsequent maintenance dose was about 5 minutes The standard intravenous (IV) preparations, Perjeta and Herceptin, were given by intravenous infusion The loading dose took about 150 minutes, and the follow-up maintenance infusion of the 2 drugs took 60-150 minutes It is worth mentioning that this is the first time that two HER2 targeted antibodies are combined into a subcutaneous injection preparation, and the administration can be completed in a few minutes This fixed dose combination of subcutaneous preparation will provide a rapid and minimally invasive drug delivery method for HER2 positive breast cancer patients undergoing intravenous infusion of perjeta and Herceptin Levi Garraway, MD, chief medical officer and head of global product development at Roche, said: "for more than 20 years, our drugs have redefined the standard of care for HER2 positive breast cancer patients Today's BLA acceptance is based on our commitment to provide patients with a faster way to use perjeta and Herceptin therapy We are working with the FDA to provide this treatment as soon as possible " The BLA is based on data from the phase III Federica study The results were presented at the 42nd San Antonio Breast Cancer Symposium (SABCS) in December 2019 A new fixed dose (FDC) perjeta + Herceptin (SC) combined with IV chemotherapy showed non inferiority in blood perjeta level (pharmacokinetics) compared with the standard IV perjeta (pertuzumab) + Herceptin (trastuzumab) + chemotherapy in eligible patients with HER2 positive early breast cancer (EBC) The efficacy and safety were comparable The Federica study reached the primary end point: compared with intravenous infusion of perjeta, SC administration of FDC showed a non inferiority of blood perjeta levels during a given interval of Administration (ctrough) The geometric mean ratio (GMR; an average used in the evaluation of pharmacokinetics) of the primary endpoint was 1.22 (90% CI: 1.14-1.31), and the lower limit of 90% CI of GMR = 1.14 was ≥ 0.80 (pre specified non inferiority limit) The secondary end point of Herceptin non inferior effect ctrough was also reached The plasma concentration of Herceptin in FDC patients was not inferior to that in patients receiving intravenous Herceptin (GMR = 1.33 [90% CI: 1.24-1.43]; GMR = 1.24, 90% CI ≥ 0.80) In this study, a non inferiority endpoint was selected to ensure that patients received adequate doses of perjeta and Herceptin over the same treatment interval compared to the established intravenous dose In addition, the total pathological complete response rate (PCR) as a secondary end point was comparable between the two treatment groups 59.7% and 59.5% of the patients receiving FDC treatment and those receiving intravenous perjeta and Herceptin treatment respectively reached the total PCR, with a difference of 0.15% (95% CI: - 8.67 to 8.97) The safety of FDC combined with chemotherapy is the same as that of perjeta + Herceptin combined chemotherapy No new safety signals, including cardiotoxicity, were found The most common adverse reactions in both groups were alopecia, nausea, diarrhea and anemia In previous studies, compared with intravenous injection of the same drug, most patients prefer subcutaneous injection (SC), the most common reason is that the time required for clinical administration is shorter Roche is currently investigating the preference of HER2 positive eBC patients for SC to FDC compared to standard IV Perjeta+Herceptin in phase II PHranceSCa study The interim results of the study will be presented at future medical conferences Perjeta + Herceptin + chemotherapy program: it has been approved by China, marking that HER2 positive breast cancer clinical treatment in the new era breast cancer is the most common cancer type among women, with more than 2 million confirmed cases every year in the world HER2 positive breast cancer is another particularly invasive breast cancer, accounting for about 15-20% of breast cancer cases After receiving Herceptin + chemotherapy, about 1 / 4 of patients with HER2 positive early breast cancer (EBC) still relapsed or died 10-11 years later, and the proportion of high-risk patients with EBC was higher Perjeta is a new type of anti HER2 drug, which can produce anti HER2 effect by inhibiting heterodimer and homodimer of HER2 The mechanism of action of perjeta and Herceptin is the same, they both target to bind HER2 receptor, but the binding sites are different The combination of the two drugs can provide a more comprehensive blockade of HER2 signaling pathway, thus preventing the growth and survival of cancer cells In the United States and the European Union, perjeta + Herceptin + chemotherapy has been approved for: (1) neoadjuvant treatment of HER2 positive early breast cancer (EBC); (2) adjuvant treatment of HER2 positive early breast cancer (EBC) with a high risk of recurrence; (3) treatment of HER2 positive advanced breast cancer (ABC) Compared with Herceptin + chemotherapy, perjeta + Herceptin + chemotherapy has significantly prolonged the survival period of patients In China, the perjeta + Herceptin + chemotherapy regimen was approved in December 2018 for adjuvant treatment of HER2 positive EBC patients with high risk of recurrence This approval marks a new era of breast cancer treatment in China! Data from the global key phase III adjuvant therapy research shows that, compared with current standard therapy Herceptin + chemotherapy, perjeta + Herceptin + chemotherapy regimen adjuvant therapy has a high risk of recurrence in HER2 positive EBC patients, significantly prolonging the non-invasive disease survival period, with controllable adverse reactions and significant clinical benefit / risk advantages (BIOON Com) original source: FDA accepts Roche's biology license application for fixed dose subcutaneous combination of perception and perception for HER2 positive burst cancer