Sunvozertinib Granted Breakthrough Therapy Designation by China CDE for the First-Line Treatment of Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for sunvozertinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who have not received prior systemic therapies.
This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. It follows the grant by the U.S. Food and Drug Administration (FDA) for the first-line setting in April this year. Sunvozertinib was previously granted BTDs by both the U.S. FDA and the China CDE for relapsed or refractory patients.
BTD procedures in the US and China are designed to expedite the development and regulatory review of new medicines that are intended to treat serious or life-threatening conditions with preliminary clinical evidence indicating substantial improvement over available therapies. Drug candidates with BTD can be considered for priority review when submitting a New Drug Application (NDA).
"The total of four Breakthrough Therapy Designations by both the U.S. and China's regulatory agencies, reflects not only sunvozertinib's transformative potential in EGFR exon20ins NSCLC, but also Dizal's commitment to developing groundbreaking new medicines to address unmet medical needs globally." said Xiaolin Zhang, PhD, CEO of Dizal, "Sunvozertinib is the world first and only oral drug approved for the treatment of lung cancer patients with EGFR exon20ins. We are accelerating ongoing clinical studies and regulatory submissions, hoping to bring this new treatment option to more patients as quickly as possible."
The CDE granted the BTD based on results from the pooled analysis of the global multi-center phase I/II study (WU-KONG1) and the phase II study (WU-KONG15) focused on patients from China. Results from these studies showed that sunvozertinib, as a single oral agent, produced a confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. Additionally, sunvozertinib is well tolerated with overall safety profile similar to classic EGFR-TKIs.
