FDA grants Breakthrough Therapy Designation to Dizal's sunvozertinib for advanced Non-Small Cell Lung Cancer with EGFR exon 20 mutations.
The FDA granted Breakthrough Therapy Designation to Dizal's sunvozertinib for first-line treatment of advanced Non-Small Cell Lung Cancer with EGFR exon 20 insertion mutations. This decision was based on phase I/II study results demonstrating a 78.6% response rate. Sunvozertinib, previously approved in China, is anticipated to receive further approvals in the US and EU.
April 07, 2024
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