Takeda's First-in-Class Lung Cancer Drug Mobocertinib Receives CDE Acceptance for NDA in China with Priority Review Designation
Takeda
Biopharmaceutical Manufacturer
SHANGHAI, July 7, 2021 /PRNewswire/ -- Takeda Pharmaceutical Company Limited today announced that its New Drug Application (NDA) for mobocertinib (TAK-788), a first-in-class innovative lung cancer therapy, has been formally accepted by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) and included in the Priority Review and Approval Program. The application is proposed for the treatment of adult patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In April 2021, the U.S. NDA for mobocertinib was granted Priority Review by the FDA. The acceptance of this marketing authorization application in China marks the first simultaneous submission in China and globally, which will help accelerate the availability of Takeda's innovative medicines to patients in China.
EGFR exon 20 insertion mutation is a rare mutation in non-small cell lung cancer (NSCLC). In China, EGFR exon 20 insertion mutations account for approximately 2.3% of all NSCLC cases.[1]. As there are currently no approved targeted therapies on the market for EGFR exon 20 insertion mutations, there is a highly urgent clinical need for patients.
Shan Guohong, President of Takeda China, stated: “In China, patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations face a significant disease burden, while current treatment options remain limited, leaving an urgent need to address patients' unmet medical needs. The acceptance by the Center for Drug Evaluation (CDE) under the National Medical Products Administration of the marketing authorization application for mobocertinib is expected to enable these patients to benefit from this innovative therapy at an earlier stage. Thanks to a series of initiatives by the Chinese government in recent years to actively deepen healthcare reform and encourage innovation, Takeda will continue to accelerate the introduction of highly innovative medicines and breakthrough therapies, striving to benefit patients in China.”
Mobocertinib is a novel, highly selective small-molecule tyrosine kinase inhibitor (TKI) developed by Takeda, targeting EGFR and human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutations. This NDA is based on the results of an international, multicenter Phase 1/2 clinical study designed to evaluate the safety, pharmacokinetics, and efficacy of oral mobocertinib in patients with non-small cell lung cancer (NSCLC), including those harboring EGFR exon 20 insertion mutations. Clinical study results demonstrated that mobocertinib elicited clinically meaningful responses in NSCLC patients with EGFR exon 20 insertion mutations who had previously received platinum-based chemotherapy, with a duration of response of up to 17.5 months (as assessed by an independent review committee).[2]。Mobocertinib was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) in December 2019; and in April 2020, it received breakthrough therapy designation from the FDA.[3]; In October 2020, mobocertinib was granted the "breakthrough therapy" designation in China.
As one of the four key regions for Takeda’s global R&D, China plays a pivotal role in global drug development. In the global pivotal second-line clinical trial of mobocertinib, the China team was the first to complete patient enrollment, contributing approximately one-third of the globally enrolled patients.
Dr. Wang Lin, Head of Takeda Asia Development Center, stated: “In China, we are committed to accelerating the introduction of innovative treatment options, including mobocertinib, into the Chinese market through our global concurrent development program. Looking ahead to fiscal year 2021, Takeda expects to submit up to 12 marketing authorization applications for new products and new indications, and obtain approvals for 6 new products and indications, thereby advancing our goal of introducing more than 15 highly innovative drugs within five years and enabling Chinese patients to access globally simultaneous innovative therapies.”
Statement:
1. This article aims to convey cutting-edge medical and pharmaceutical information and does not constitute a recommendation or promotion of any drug or diagnostic and treatment protocol.
2. For more information on diseases, medications, or diagnosis and treatment, please consult a healthcare professional.
[1] Zhefeng Liu, Lin Wu, Jun Cao, et al. Clinical characterization of ERBB2 exon 20 insertions and heterogeneity of outcomes responding to afatinib in Chinese lung cancer patients . Onco targets and therapy
[2] Caicun Zhou, Mobocertinib in NSCLC with EGFR Exon 20 Insertions: Results from Exclaim and Platinum-Pretreated Patient Populations, Jan 2021, 2020 World Conference of Lung Cancer.