Centus Biotherapeutics Announces Positive CHMP Opinion for FKB238, Biosimilar Bevacizumab

On July 27, 2020 Centus Biotherapeutics Ltd., a joint venture between Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca PLC (LSE/STO/NYSE: AZN), reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of Equidacent (Product Code: FKB238), the company’s biosimilar to Avastin (bevacizumab), for indications including metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer, persistent, recurrent, or metastatic carcinoma of the cervix (Press release, Centus Biotherapeutics, JUL 27, 2020, View Source,-Details%20Category%3A%20Antibodies&text=D.%20said%2C%20%E2%80%9CI%20am,to%20patients%20throughout%20European%20countries. [SID1234562391]).

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The decision of the European Commission (EC) on the approval is expected in September 2020, which would grant Centus the marketing authorization in 27 European Union (EU) member states, the United Kingdom (UK) and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

Centus President Hiroshi Ohashi, Ph. D. commented, "We are happy to receive a positive CHMP opinion toward the approval of Equidacent, our bevacizumab biosimilar. We will continue to make every effort to obtain the approval for Equidacent, which could help patients and healthcare professionals."

Fujifilm Kyowa Kirin Biologics President and CEO Atsushi Matsumoto, Ph. D. said, "I am delighted that CHMP decided to recommend the approval of the proposed biosimilar bevacizumab. We will continue our efforts to bring high quality and affordable biosimilars to patients throughout European countries."

Centus was established in 2015 as a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca. Fujifilm Kyowa Kirin Biologics has granted an exclusive license to Centus for the development, manufacture and commercialization of Equidacent on a worldwide basis. Centus has been promoting clinical development of Equidacent.

Data submitted as part of the Marketing Authorization Application for Equidacent included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the bevacizumab reference product, Avastin. The phase 3 clinical study, AVANA, conducted by Centus, demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Avastin, in non-small cell lung cancer patients.

About Bevacizumab
Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A). It reduces growth and metastasis of several solid tumors.

Chugai Announces 2020 Half Year Results

On July 27, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first half of fiscal year 2020 (Press release, Chugai, JUL 27, 2020, View Source [SID1234562389]).

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"We had another successful quarter with a limited impact from the COVID-19 pandemic on financial performances though we saw wide-ranging influences on our activities. We obtained approval for the first recycling antibody Enspryng, one of our next growth drivers. Also, structural reforms of corporate functions progressed well to enhance the business platform. Under increasingly uncertain business conditions, we will continue striving to realize innovation that is only possible at Chugai," said Tatsuro Kosaka, Chugai’s Chairman and CEO.

[Half year results for 2020]

Despite the slight decrease in domestic sales affected by the NHI drug price revisions and the market penetration of generic drugs, Chugai reported a double-digit growth year-on-year in revenues and operating profit for the half year (Core-basis), due to increases both in overseas sales and royalties and other operating income.

Revenues increased by 14.9%. Among sales, domestic sales decreased by 2.6% due to a decrease in sales of mainstay products mainly in the Oncology and Renal diseases areas affected by the NHI drug price revisions in April this year, and the market penetration of generic drugs. On the other hand, overseas sales increased by 39.5% due to an increase in export of Actemra to Roche, including those for clinical trials for COVID-19 pneumonia, and the export of Hemlibra to Roche at a regular shipment price. Royalties and other operating income increased by 64.9% due to a large increase in royalties for Hemlibra and its profit-sharing income as well as an increase in other operating income resulting from one-time income.

Cost to sales ratio improved by 2.2 percentage points at 42.9% mainly due to a larger proportion of in-house products in the total product mix. Operating expenses increased slightly in total. Marketing and distribution expenses and general and administration expenses decreased due to lower business activities caused by the spread of COVID-19. Research and development expenses recorded a double-digit increase with the projects progressing largely as expected at the beginning of the year. Operating profit increased by 38.8% due to the strong increase in royalties and profit-sharing income, and a better cost to sales ratio.

The Company also made a good progress in research and development. Chugai obtained regulatory approval for the anti-IL-6 receptor recycling antibody Enspryng, created by Chugai for the prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica) in Japan in June. Also, Chugai started domestic Phase III study for Hemlibra for the treatment of acquired hemophilia A. Regarding projects for COVID-19, a domestic Phase III study for Actemra for the hospitalized patients with severe COVID-19 pneumonia is underway, and Chugai aims to submit a regulatory application in 2020. Chugai Pharmabody Research Pte. Ltd. (CPR) began a joint research on a therapeutic antibody to fight COVID-19 with the Agency for Science, Technology and Research (A*STAR).

[Initiatives for COVID-19 and impact on performance]

Regarding the impact of COVID-19 on performance during the six months under review, there were no major negative impacts on revenues and profits. However, the company faced a range of influences on the progress of business activities as below.

Product supply system maintained stable by taking measures to prevent infection of employees and business partners. No impacts on the product supply have been seen both in Japan and overseas up to now.
Delay of the introduction of new products and those with additional indications, such as Tecentriq and Hemlibra, in the domestic market due to various reasons including restrained sales activities and decreases in hospitalizations and outpatients.
Increase in export of Actemra to Roche, including those for clinical trials for COVID-19 pneumonia.
No major impacts on the timing of regulatory filing or approval.
Some delays in the initiation and progress of clinical trials for projects under development. These delays are expected to be resolved in time.
No delays in drug discovery activities for high-priority projects.
Construction for Chugai Life Science Park Yokohama temporarily suspended. Construction resumed entirely from June with limited impacts on the overall construction schedule.
Some expenses suppressed mainly due to cancellation of overseas travels and restrained sales activities in Japan.

Calquence recommended for approval in the EU by CHMP for chronic lymphocytic leukaemia

On July 27, 2020 AstraZeneca’s Calquence (acalabrutinib) reported that it has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.1 (Press release, AstraZeneca, JUL 27, 2020, View Source [SID1234562386])

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from two Phase III clinical trials, ELEVATE TN in patients with previously untreated CLL, and ASCEND in patients with relapsed or refractory CLL.

In the ELEVATE TN trial, Calquence combined with obinutuzumab and as monotherapy reduced the risk of disease progression or death by 90% and 80%, respectively, compared to standard chemo-immunotherapy treatment chlorambucil plus obinutuzumab, in patients with previously untreated CLL.2 In the ASCEND trial, 88% of patients with relapsed or refractory CLL taking Calquence remained alive and free from disease progression after 12 months compared to 68% of patients on rituximab combined with idelalisib or bendamustine.3

Across both trials, the safety and tolerability of Calquence were consistent with its known profile.2,3

José Baselga, Executive Vice President, Oncology R&D said: "With its outstanding efficacy and tolerability profile, Calquence can offer important advantages to patients with chronic lymphocytic leukaemia who are typically older, facing multiple comorbidities and often require treatment for many years. This positive recommendation brings us closer to providing a much-needed new treatment option to patients in Europe who are suffering from this chronic blood cancer."

The CHMP recommendation is for Calquence monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL and for Calquence monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy.

Calquence is approved in the US and in several other countries around the world for the treatment of adult patients with CLL and for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is not approved for MCL in Europe.

Chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults, with an estimated 105,000 new cases globally in 2016, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.1,4,5,6 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.4 B-cell receptor signalling through Bruton’s tyrosine kinase is one of the essential growth pathways for CLL.

ELEVATE TN

ELEVATE TN (ACE-CL-007) was a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. Patients 65 years of age or older, or between 18 and 65 years of age with a total Cumulative Illness Rating Scale (CIRS) >6 or creatinine clearance of 30 to 69mL/min, were enrolled. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg approximately every 12 hours until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg approximately every 12 hours until disease progression or unacceptable toxicity).2,7

The primary endpoint was progression-free survival (PFS) in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint was IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints included objective response rate, time to next treatment and overall survival.2,7

ASCEND

ASCEND (ACE-CL-309) was a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously treated patients with CLL. In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received investigator’s choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy.3,7

The primary endpoint was PFS assessed by an IRC, and key secondary endpoints included physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient-reported outcomes and time to next treatment.3,7

Calquence

Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.7,8 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.7

Calquence is approved in the US and in several countries around the world for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) and for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The US MCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 23 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenström macroglobulinaemia, follicular lymphoma, and other haematologic malignancies.

AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Company’s haematology franchise includes two medicines approved by the US Food and Drug Administration and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZeneca’s haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

Imfinzi recommended for approval in the EU by CHMP for extensive-stage small cell lung cancer

On July 27, 2020 AstraZeneca’s Imfinzi (durvalumab) reported that it has been recommended for marketing authorisation in the European Union (EU) for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.1,2 (Press release, AstraZeneca, JUL 27, 2020, View Source [SID1234562385])

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the Phase III CASPIAN trial for Imfinzi plus chemotherapy, which have also been published in The Lancet.3

The trial showed that Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit for the 1st-line treatment of patients with ES-SCLC, reducing the risk of death by 27% versus chemotherapy alone (based on a hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047). Results also showed an increased confirmed objective response rate in the Imfinzi plus chemotherapy arm (68% versus 58% for chemotherapy alone) and that Imfinzi added to chemotherapy delayed the time it took for lung cancer-related symptoms to worsen.4

An updated analysis recently showed sustained efficacy for Imfinzi plus chemotherapy after a median follow up of more than two years (OS HR: 0.75; 95% CI 0.62-0.91; nominal p=0.0032). The safety and tolerability for Imfinzi plus chemotherapy were consistent with the known safety profile of these medicines. No patients tested positive for treatment-emergent anti-drug antibodies to Imfinzi.

Luis Paz-Ares MD, Ph.D., Chair, Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain and principal investigator in the Phase III CASPIAN trial said: "The CASPIAN trial shows that Imfinzi plus a choice of platinum-etoposide chemotherapies offers an important new 1st-line treatment option for extensive-stage small cell lung cancer, providing a sustained survival benefit with a well-tolerated treatment. For many physicians in Europe, cisplatin is a preferred chemotherapy in this setting, and this recommendation is a vital step toward bringing an immunotherapy combination with cisplatin to these patients in Europe for the first time."

José Baselga, Executive Vice President, Oncology R&D, said: "Imfinzi has the potential to address a critical unmet need for patients with extensive-stage small cell lung cancer in Europe who have few options to treat this aggressive and devastating disease. We look forward to delivering a new standard of care that significantly improves survival with a choice of chemotherapies and convenient dosing every four weeks during maintenance."

The CHMP recommendation is for Imfinzi in combination with etoposide and either carboplatin or cisplatin for the 1st-line treatment of adults with ES-SCLC. The CASPIAN trial used a fixed dose of Imfinzi (1500mg) administered every three weeks for four cycles while in combination with chemotherapy and then every four weeks until disease progression.

Imfinzi in combination with etoposide and either carboplatin or cisplatin is approved in the US and several other countries around the world for the treatment of ES-SCLC in the 1st-line setting and is currently under regulatory review in Japan and other countries.

Small cell lung cancer

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one fifth of all cancer deaths.5 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC.6 About two thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.7 Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.7

CASPIAN

CASPIAN was a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of 805 patients with ES-SCLC. The trial compared Imfinzi in combination with etoposide and either carboplatin or cisplatin chemotherapy, or Imfinzi and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone. In the experimental arms, patients were treated with four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and optional prophylactic cranial irradiation. The trial was conducted in more than 200 centres across 23 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint was OS in each of the two experimental arms. In June 2019, the CASPIAN trial met one primary endpoint of demonstrating OS for Imfinzi plus chemotherapy at a planned interim analysis. In March 2020, the second experimental arm with tremelimumab did not meet its primary endpoint of OS.

Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries, based on the Phase III PACIFIC trial. Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and a small number of other countries.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer, ovarian cancer, endometrial cancer and other solid tumours.

AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. AstraZeneca aims to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with the approved medicines Iressa (gefitinib) and Tagrisso (osimertinib) and its ongoing Phase III trials LAURA, NeoADAURA and FLAURA2.8-10

AstraZeneca is committed to addressing tumour mechanisms of resistance through the ongoing Phase II trials SAVANNAH and ORCHARD which test Tagrisso in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, is in development for metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC including trials in combination with other anticancer treatments.

An extensive Immuno-Oncology development programme focuses on lung cancer patients without a targetable genetic mutation which represents up to three-quarters of all patients with lung cancer.11 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON and PEARL) and for patients in earlier stages of disease including potentially-curative settings (Phase III trials MERMAID-1, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in combination with tremelimumab and/or chemotherapy. Imfinzi is also in development in the Phase II trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline including Enhertu.

AstraZeneca’s approach to Immuno-Oncology

Immuno-oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

Sysmex Launches OncoGuide™ NET Expert Panel Support System in Cancer Genome Profiling(PDF?151KB)

On July 27, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported the July 2020 launch of its OncoGuideTM NET1 expert panel support system (the "System"), which enhances the administrative efficiency of expert panels2 in cancer genome profiling (Press release, Sysmex, JUL 27, 2020, View Source [SID1234562369]). The OncoGuideTM NET allows for the sharing of information needed for discussions by expert panels, which consist of experts in various disciplines from multiple medical institutions, and arrangement of session schedules. When connected to the OncoGuideTM Portal, 3 the System retrieves test results. With these functions being managed under an information security environment complying with the Three Guidelines from Three Ministries (3G3M),4 the System supports the establishment of an efficient framework for cancer genomic medicine.

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Sysmex received manufacturing and marketing approval in Japan for the first time and then approval for insurance coverage for its OncoGuideTM NCC Oncopanel System to be used in cancer genome profiling, making the system readily available to medical institutions. At the same time, we have implemented a complete domestic testing service, with comprehensive support that includes an assay service by RIKEN GENESIS. 5

One of the challenges of spreading cancer genomic medicine at an accelerated pace in Japan’s healthcare setting is how they can go about increasing the efficiency of expert panels, in which medical professionals from multiple institutions participate. In response to the expectations of such medical professionals, in July 2020, we will start providing the System to cancer genomic medicine core hospitals, hub hospitals, and liaison hospitals that organize expert panels.

The System allows for the sharing of patient information and analysis results, which are necessary for discussions by expert panels, a process with a particularly demanding workload, and efficient arrangement of session schedules. When connected to the OncoGuideTM Portal, the System performs automatic input of IDs and other data and retrieves test results. The System is managed under an advanced information security environment complying with the Three Guidelines from Three Ministries (3G3M) by the Ministry of Health, Labour and Welfare, the Ministry of Economy, Trade and Industry, and the Ministry of Internal Affairs and Communications of Japan.

Going forward, Sysmex aims to contribute to the clinical implementation of genomic medicine in Japan by providing high-value-added information useful in the diagnosis and treatment of cancer and the selection of anti-cancer drugs. To this end, we will expand the functions of the System, such as linking case information files of the Center for Cancer Genomics and Advanced Therapeutics (CCAT)6 and analyzing the activities by previous expert panels, in addition to enhancing the efficiency of expert panels. By delivering the OncoGuideTM NET, together with the cancer genome profiling system, Sysmex will lead the efforts towards realizing personalized medicine, so that we can reduce the workload of medical professionals, improve patients’ quality of life (QOL), and contribute to the advancement and progress of healthcare.

References
"Sysmex Receives Manufacturing and Marketing Approval to Use the OncoGuideTM NCC Oncopanel System in Cancer Genome Profiling," released on December 25, 2018 View Source

"Commencement of Assay Service Using the OncoGuideTM NCC Oncopanel System in Cancer Genome Profiling," released on February 21, 2019 View Source

"The OncoGuideTM NCC Oncopanel System Receives Insurance Coverage for Use in Cancer Genome Profiling," released on May 31, 2019 View Source

Terminology

1 OncoGuideTM NET: NET is short for Network for Expert Panel Team.

2 Expert panel: A committee comprised of experts from diverse fields, including cancer medication, medical genetics, genetic counseling, pathology, molecular genetics, and cancer genomic medicine, from multiple medical institutions, as well as the attending physician. Determines implications of analysis results of cancer genome profiling and suggests therapies optimized for individual patients.

3 OncoGuideTM Portal: Monitors progress in testing at providers of lab-assay services using the OncoGuideTM NCC Oncopanel System and retrieves electronic files of test reports.

4 Three Guidelines from Three Ministries (3G3M): Refers collectively to the three separate guidelines drawn up by the Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry, and Ministry of Internal Affairs and Communications of Japan in line with the roadmap for the development of medical information safety management guidelines for reasons of security, etc. of electronic medical information.

5 RIKEN GENESIS Co., Ltd.: A subsidiary of Sysmex Corporation that provides lab-assay services for genetic testing.

6 Center for Cancer Genomics and Advanced Therapeutics (C-CAT): A platform for constructing a "cancer genomics information repository," a master database of sequence information and clinical information obtained from genomic analyses conducted by hospitals implementing cancer genomic medicine and elsewhere, and for building a cancer genome knowledge database for interpreting and determining the clinical implications of genome analysis results.