The first three negative breast cancer ADC drug! Immunomedics potential blockbuster sacituzumab govitecan is under review in the US!

December 27, 2019 / BIOON / -- immunomedics is a clinical stage biopharmaceutical company, focusing on the development of monoclonal antibody based therapies for targeted treatment of cancer and other serious diseases Recently, the company announced that the U.S Food and Drug Administration (FDA) has accepted a resubmitted biological product licensing application (BLA), which seeks to approve the antibody drug conjugate (ADC) sacituzumab govitecan (R & D Code: immu-132) for metastatic triple negative breast cancer that has previously received at least two treatments for metastatic diseases (mtnbc) patients The resubmitted BLA's prescription drug user fee Act (PDUFA) target date is June 2, 2020 In May last year, immunomedics first submitted BLA to the FDA for accelerated approval of sacituzumab govitecan for patients with mtnbc who had previously received at least two treatments for metastatic disease In July last year, the FDA accepted the BLA and granted a priority review In January, however, the FDA issued a full response letter (CRL) In CRL, FDA refused to approve sacituzumab govitecan for manufacturing problems However, the approval related issues in CRL only focus on chemistry, manufacturing and control, and there is no need to generate new clinical or preclinical data Dr Behzad Aghazadeh, executive chairman of immunomedics, said: "we are pleased that FDA has accepted our resubmitted bla, which is our top priority in 2019 We look forward to working closely with FDA during the BLA review to bring this potentially transformative therapy to the mtnbc patient population as soon as possible " Sacituzumab govitecan is a new and innovative antibody drug conjugate (ADC) drug It is composed of human IgG1 antibody targeting to the Trop-2 antigen and SN-38, an active metabolite of irinotecan, a topoisomerase I inhibitor Trop-2 is a cell surface glycoprotein expressed in more than 90% of TNBC Industry analysts have previously thought that sacituzumab govitecan is a significant progress compared with standard care according to the phase II clinical data obtained If approved, the drug will become the first and only antibody drug conjugate (ADC) drug to treat mtnbc, with a peak sales expected to reach more than US $1 billion In the last update in December last year, immunomedics reported the phase II data of 108 patients According to the evaluation of the independent review committee, the total remission rate induced by sacituzumab govitecan was 34%, and the median remission duration was 9 months At present, immunomedics is also carrying out a confirmatory phase III clinical study on sacituzumab govitecan in the treatment of mtnbc In addition to mtnbc, immunomedics is evaluating sacituzumab govitecan for treatment of many other types of cancer In July last year, AstraZeneca and immunomedics reached a strategic cooperation to develop PD-L1 tumor immunotherapy - imfinzi (durvalumab) in combination with sacituzumab govitecan for the first-line treatment of TNBC and urothelial cancer; in November last year, the two sides expanded cooperation to include metastatic non-small cell lung cancer (mnsclc) Breast cancer is the most common type of cancer among women, with more than 2 million confirmed cases every year around the world Three negative breast cancer (TNBC) accounts for about 15% of all breast cancers Compared with other types of breast cancer, TNBC is more common in women under 50 years old TNBC, especially estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER-2), is a kind of breast cancer with negative expression TNBC has no effect on hormone therapy and HER2 targeted therapy (e.g roxithin Herceptin) The choice of clinical treatment is very limited, which mainly depends on chemotherapy It is worth mentioning that in March this year, tecentriq, the Roche PD-L1 tumor immunotherapy, was approved by the US FDA, and the combination chemotherapy (Abraxane) was used to treat PD-L1 positive patients with locally advanced or metastatic triple negative breast cancer (TNBC) This approval makes tecentriq + Abraxane combination the first cancer immunotherapy for TNBC Original source: immunomedia announcements FDA acceptance for filling of biology license application permission for sacituzumab govitecan to treat metastatic triple negative breath cancer