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Sacituzumab Govitecan, A Kind of ADC Drug Against Triple-Negative Breast Cancer

On April 22, the FDA approved sacituzumab govitecan for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. It is a next generation antibody-drug conjugate designed by Immunomedics Inc.


Sacituzumab govitecan is the first antibody-drug conjugate approved by the FDA specifically for relapsed or refractory metastatic triple-negative metastatic breast cancer. It is also the first FDA-approved anti–Trop-2 antibody-drug conjugate. The agent is a Trop-2–directed antibody and topoisomerase inhibitor drug conjugate.


Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of sacituzumab govitecan represents a new targeted therapy for patients living with this aggressive malignancy.


IMMU-132-01


The FDA approved sacituzumab govitecan based on the results of the phase II IMMU-132-01 clinical trial of 108 patients with metastatic triple-negative breast cancer who had received a range of 2 to 10 prior treatments for metastatic disease. Patients received sacituzumab govitecan at 10 mg/kg intravenously on days 1 and 8 every 21 days. Tumor imaging was obtained every 8 weeks, and patients were treated until disease progression or intolerance to therapy.


The efficacy of sacituzumab govitecan was based on the overall response rate. The overall response rate was 33.3% (95% confidence interval [CI] = 24.6%–43.1%), with a median duration of response of 7.7 months (95% CI = 4.9–10.8). Of the patients with a response to sacituzumab govitecan, 55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more months.


The most common reported side effects (occurring in 25% or more of patients) were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain. The most common grade 3 or 4 adverse events (occurring in more than 5% of patients) were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea, and vomiting.


Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment, and no severe cases of neuropathy or interstitial lung disease.


The prescribing information for sacituzumab govitecan includes a Boxed Warning to advise health-care professionals and patients about the risk of severe neutropenia and severe diarrhea.


Continued approval of sacituzumab govitecan may be contingent upon verification of clinical benefit in the confirmatory phase III ASCENT study, which was recently halted by the independent data safety monitoring committee for compelling evidence of efficacy across multiple endpoints.


The recommended sacituzumab govitecan dose is 10 mg/kg administered by intravenous infusion administered on days 1 and 8 every 21 days until disease progression or unacceptable toxicity.


Biochempeg, a leading PEG supplier can provide GMP standard PEG derivatives and ADC linkers with small quantity or bulk orders to customers all over the world based on their special quality requirements. It provides 2-((Azido-PEG8-carbamoyl)methoxy)acetic acid (CAS NO.: 846549-37-9), which is a fragment of IMMU-132.
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According to the new market research report “Particle Therapy Market by Type (Heavy Ion, Proton Therapy), Products (Cyclotron, Synchrotron, Synchrocyclotron), Services, System (Single-room, Multi-room), Cancer Type (Pediatric, Prostate, Breast), Application (Treatment, Research) – Forecast to 2023“, published by MarketsandMarkets™, the global Particle Therapy Market is projected to reach USD 1,349 million by 2023 from USD 865 million in 2018, at a CAGR of 9.3%. Browse in-depth TOC on “Particle Therapy Market“ 80 – Tables 36 – Figures 138 – Pages Download PDF Brochure:  https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=12809137 The major factors driving the growth of the Particle Therapy Market are the growing global prevalence of cancer, growing adoption of particle therapy in clinical trials, advantages offered by particle therapy over photon therapy, and the increasing number of particle therapy centers worldwide. 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Growing awareness about the research applications of particle therapy systems, development of cost-effective and technologically advanced diagnostic and therapeutic particle therapy systems, and increasing industry-academia collaborations in the field of research are the key factors driving the growth of this segment. Asia Pacific to dominate the Particle Therapy Market during the forecast period The Particle Therapy Market is segmented into four regional segments, namely, North America, Europe, Asia Pacific, and the Rest of the World. The Asia Pacific region is expected to account for the largest share of the global Particle Therapy Market in 2018, and this trend is expected to continue during the forecast period. The Asia Pacific region is expected to offer significant growth opportunities for players operating in the Particle Therapy Market owing to the increasing healthcare expenditure and growing initiatives to promote the use of advanced particle therapy technologies in Asia Pacific countries. Request for sample pages @ https://www.marketsandmarkets.com/requestsampleNew.asp?id=12809137 The major players operating in the Particle Therapy Market are Ion Beam Applications SA (Belgium), Varian Medical Systems, Inc. (US), Hitachi, Ltd. (Japan), Provision Healthcare (US), Mevion Medical Systems, Inc. (US), Sumitomo Heavy Industries, Ltd. (Japan), Optivus Proton Therapy, Inc. (US), ProTom International, Inc. (US), Advanced Oncotherapy plc (UK), and Danfysik A/S (Denmark). Browse Adjacent Markets @ Medical Devices Market Research Reports & Consulting Radiotherapy Market by Product (LINAC, CyberKnife, Gamma Knife, Tomotherapy, Particle Therapy, Cyclotron), Procedure (External (IMRT, IGRT, 3D-CRT) Internal (LDR, HDR)), Application (Prostate, Breast, Lung), End User (Hospitals) – Global Forecasts to 2026 https://www.marketsandmarkets.com/Market-Reports/radiotherapy-monitoring-devices-market-567.html Patient Positioning System Market by Product (Tables (Surgical Tables, Radiolucent Imaging Tables), Accessories), Application (Surgery, Cancer Therapy, Disease Diagnosis), and End User (Hospitals, Ambulatory Surgery Center) – Global Forecast to 2022 https://www.marketsandmarkets.com/Market-Reports/patient-positioning-system-market-12586699.html About MarketsandMarkets™ MarketsandMarkets™ provides quantified B2B research on 30,000 high growth niche opportunities/threats which will impact 70% to 80% of worldwide companies’ revenues. Currently servicing 7500 customers worldwide including 80% of global Fortune 1000 companies as clients. Almost 75,000 top officers across eight industries worldwide approach MarketsandMarkets™ for their painpoints around revenues decisions. Our 850 fulltime analyst and SMEs at MarketsandMarkets™ are tracking global high growth markets following the “Growth Engagement Model – GEM”. The GEM aims at proactive collaboration with the clients to identify new opportunities, identify most important customers, write “Attack, avoid and defend” strategies, identify sources of incremental revenues for both the company and its competitors. MarketsandMarkets™ now coming up with 1,500 MicroQuadrants (Positioning top players across leaders, emerging companies, innovators, strategic players) annually in high growth emerging segments. 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