On July 7, 2021 Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) ("Takeda") reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) has accepted the company’s New Drug Application (NDA) for mobocertinib (TAK-788) and granted priority review for this Class-1 innovative drug, for the treatment of adult patients with non-small cell lung cancer(NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations (Press release, Takeda, JUL 7, 2021, View Source [SID1234586735]). Mobocertinib is the first oral therapy specifically designed to target EGFR Exon20 insertion mutations. The U.S. Food and Drug Administration (FDA) recently granted priority review for the company’s New Drug Application for mobocertinib with a Prescription Drug User Fee Act (PDUFA) target action date set for October 26, 2021.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Patients with EGFR Exon20 insertion+ mNSCLC face critical unmet needs in China," said Sean Shan, president of Takeda in China. "The acceptance by CDE marks an important step to accelerate the delivery of innovative treatments to patients with limited therapeutic options. The Chinese government’s healthcare reforms are rewarding innovation which also present an opportunity for Takeda’s current portfolio and pipeline of innovative and life transforming medicines."
The EGFR Exon20 insertion mutation is a rare mutation in non-small cell lung cancer (NSCLC). In China, the incidence of NSCLC with the EGFR Exon20 insertion mutations accounts for about 2.3 percent of all NSCLC cases[1]. Currently, there are no approved therapies targeting EGFR Exon20 insertion mutations, and the current EGFR TKIs and chemotherapy provide limited benefits for these patients whose clinical needs are very urgent[2].
"Takeda is committed to bringing established innovative products as well as exciting, new molecular entities like mobocertinib to patients in China. And, when possible, ensuring submission and approval occurs in a similar timeframe as in other regions," said Lin Wang, Head of the Takeda Development Center Asia. "We’re preparing for an exciting period of growth and expansion in fiscal year 2021, with the potential for up to 12 submissions and six approvals, which will contribute significantly toward our goal of delivering more than 15 innovative medicines to patients in China by fiscal year 2024."
The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC.