FDA Grants Breakthrough Therapy Designation to ...
Sunvozertinib received FDA breakthrough therapy designation for first-line treatment of EGFR exon 20 insertion mutation-positive NSCLC, showing efficacy and tolerability in trials. Approved in China for similar use, it demonstrated a 78.6% ORR and 12.4 months median PFS in the WU-KONG1 trial. Safety data indicated manageable adverse effects. Global phase 3 studies are ongoing, with U.S. and EU approvals anticipated in 2024.
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The FDA granted breakthrough therapy designation to sunvozertinib for frontline treatment of NSCLC with EGFR exon 20 insertion mutations, based on phase 1/2 WU-KONG1 trial results showing a 78.6% ORR and 12.4 months median PFS. Sunvozertinib, an oral agent, offers safety and compliance advantages, with ongoing global studies and anticipated regulatory submissions.
Dizal Pharmaceutical's sunvozertinib received FDA breakthrough therapy designation for treating NSCLC with EGFR exon 20 mutations, showing a 78.6% response rate and 12.4 months mPFS. It targets challenging mutations effectively, with a 60.8% cORR in the WU-KONG6 study. Global phase III trials are ongoing, with US and EU NDAs expected in 2024.
Sunvozertinib received FDA breakthrough therapy designation for first-line treatment of EGFR exon 20 insertion mutation-positive NSCLC, showing efficacy and tolerability in trials. Approved in China for similar use, it demonstrated a 78.6% ORR and 12.4 months median PFS in the WU-KONG1 trial. Safety data indicated manageable adverse effects. Global phase 3 studies are ongoing, with U.S. and EU approvals anticipated in 2024.