Sunvozertinib

The submission is supported by data from the pivotal WU-KONG1 Part B study, which featured in an oral session at the 2024 ASCO Annual Meeting Sunvozertinib is the world's first and only oral drug approved for NSCLC patients with EGFR exon20ins SHANGHAI, Nov. 8, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Previously, sunvozertinib received accelerated approval in China, making it the world's first and only oral drug for NSCLC patients with EGFR exon20ins. It has also been granted Breakthrough Therapy Designations (BTDs) by both the U.S. FDA and the China Center for Drug Evaluation (CDE) for treating EGFR exon20ins NSCLC. The submission is supported by results from the WU-KONG1 Part B study, a multinational pivotal study investigating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients from Asia, Europe, North America, and South America. Sunvozertinib met the primary endpoint by demonstrating statistically significant and clinically meaningful objective response rate (ORR), as assessed by an independent review committee (IRC), while maintaining a manageable safety profile. Data from the study were presented in an oral session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. "We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC." said Xiaolin Zhang, PhD, CEO of Dizal. "The filing for approval of sunvozertinib marks Dizal's first NDA submission to the FDA, which represents an important step forward as we continue our efforts to address unmet medical needs globally. We look forward to working closely with the FDA on their review of our application." Lung cancer is the leading cause of cancer incidence and mortality worldwide. NSCLC accounts for approximately 80%-85% of all lung cancers. Patients with NSCLC harboring EGFR exon20ins are reported to have poorer prognosis than those with other EGFR sensitizing mutations. Sunvozertinib, with its innovatively designed molecular structure, provides enhanced efficacy, safety, and ease of administration. References： About s unvozertinib (DZD9008) Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine . About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies, both of which have already been launched in China. To learn more about Dizal, please visit , or follow us on Linkedin or Twitter. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. 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Oct. 10, 2024 -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), an innovative company in the field of precision oncology, and Dizal, a global biopharmaceutical company focused on malignant tumors and immunological diseases, jointly announced that the companion diagnostic (CDx) for EGFR exon 20 insertion mutation (exon20ins) for sunvozertinib, developed through their collaboration, has been approved by the National Medical Products Administration (NMPA) of China. This marks the first co-developed NGS-based CDx for lung cancer approved by NMPA since the release of the CDx guideline in China. The approval of this CDx test is the result of the simultaneous development of Burning Rock's independently developed LungCure CDx (a kit for the combined detection of 9 human gene mutations) and Dizal's innovative EGFR exon20ins targeted therapy - sunvozertinib, providing an innovative precision treatment solution for non-small cell lung cancer patients with EGFR exon20ins. Mr. Yusheng Han, Founder and CEO of Burning Rock stated: "We are thrilled to have carried out a deep companion diagnostic collaboration with the global biopharmaceutical company Dizal. This collaboration sets a standardized and high-quality benchmark for the concurrent development of companion diagnostics for anti-tumor drugs. Burning Rock is strategically positioned to drive companion diagnostic development on a global scale for pharmaceutical companies. By integrating our resources and experience in the field of oncology diagnosis and treatment, we are confident that we can offer more precise treatment options for Chinese cancer patients." Dr. Xiaolin Zhang, Founder, Chairman, and CEO of Dizal stated: “This achievement can be attributed to the collaborative innovation of the professional teams from both sides and reflects our unremitting pursuit of creating clinical value for the benefit of patients. Precision therapy is one of the core strategies of Dizal. Dizal will continue to adhere to the discovery and development of groundbreaking new medicines, and work with our partners to bring new hope of precision treatment to more patients.” Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval was based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed objective response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 61%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in ≥ second-line (WU-KONG1 Part B) and first-line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2). On March 11, 2022, the National Medical Products Administration (NMPA) officially approved the registration of the company's Human Nine-Gene Mutation Joint Detection Kit (reversible termination sequencing) (commercially known as "LungCure CDx") as a Class III medical device product. This test kit is Burning Rock’s second NMPA-approved companion diagnostic multi-gene tumor mutation co-detection test kit based on high-throughput sequencing technology and meeting companion diagnostic standards. It can be used for in vitro detection of multiple mutation statuses of EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET genes in non-small cell lung cancer patients, including point mutations, insertions/deletions, fusions (rearrangements), amplifications, etc., to comprehensively guide targeted therapy for non-small cell lung cancer. "LungCure CDx" has undergone rigorous clinical validation, enhancing the detection capability of rare mutation types. At the same time, "LungCure CDx" has entered into companion diagnostics development strategic partnerships with several well-known domestic and international pharmaceutical companies to jointly promote the development of standardized and precise diagnosis and treatment in oncology. Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies, both of which have already been launched in China. Burning Rock Biotech Limited (NASDAQ:BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of 1) NGS-based therapy selection testing for late-stage cancer patients, 2) Global pharmaceutical services on biomarker detection and companion diagnostics development, and 3) Early cancer detection which has moved beyond proof-of-concept R&D into the clinical validation stage. Burning Rock provides dedicated services to pharmaceutical partners, encompassing genomic data solutions, clinical trial solutions, precision patient recruitment, and companion diagnostics development and commercialization. Burning Rock has achieved two NMPA-approved IVD kits, four assays with CE marking, and a breakthrough device designation (BDD) received from both US FDA and China NMPA for multi-cancer detection blood test. The content above comes from the network. if any infringement, please contact us to modify.