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Nov 17, 2024, 07:43

Tanja Obradovic: Important milestone for Dizal Pharmaceutical with sunvozertinib NDA submission

Tanja Obradovic, Vice President of Oncology Scientific Affairs at ICON PLCh, shared a post on LinkedIn:

“Dizal Pharmaceutical just announced quite important milestone of submitting NDA for FDA approval of sunvozertinib (irreversible EGFR inhibitor with strong activity for EGFR exon 20 ins in relapsed/refractory NSCLC patients based on WU-KONG1 Part B trial results). Few important things on development strategy to point out.

NSCLC patient population is quite wide and includes patients treated with EGFR and HER2 antibodies as well as PD(L)-1 inhibitors in previous lines (up to 3 lines of therapy). In addition, it includes patients with prior treatment with currently approved EGFR TKIs for sensitizing or T790M resistance mutations (examples: gefitinib, erlotinib, osimertinib, afatinib, dacomitinib) unless the patient had an objective response and subsequent progression.

Submitted NDA data is from the large global PhI/PhII trial that explored multiple sunvozertinib doses. Of importance is that confirmatory global PhIII trial in the 1st line started while China’s National Medical Products Administration (NMPA) already approved sunvozertinib for treating advanced NSCLC with EGFR exon20ins following platinum-based chemotherapy.

Considering mobocertinib pull out from the US and current status of poziotinib, this development is a good news for NSCLC patients with tumors harboring EGFR exon20ins with additional plus side for sunvozertinib since it is developed as oral form.”

Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.

cancer Dizal Pharmaceutical EGFR EGFR exon 20 ins EGFR TKIs FDA approval irreversible EGFR inhibitor NSCLC OncoDaily Oncology PD(L)-1 inhibitors relapsed/refractory NSCLC Sunvozertinib Tanja Obradovic WU-KONG1

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