Evicenter
P&T meetings

Ivonescimab

EGFR-mutated non-small-cell lung cancer

Launch
Not announced
Last updated
79 sources

Product information and disease descriptionProduct description

Phase of product development

5 evidence topics · 7 sources

Regulatory status

“Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).” (opens the source at this quote in a new tab)

Regulatory submission: BLA submitted in the fourth quarter of 2025

“The BLA was submitted during the fourth quarter of 2025.” (opens the source at this quote in a new tab)

“Based on the results of the HARMONi clinical trial, Summit submitted a BLA in the fourth quarter of 2025 in order to seek approval for ivonescimab plus chemotherapy in this setting.” (opens the source at this quote in a new tab)

Launch

No evidence found.

FDA review milestone

“PDUFA Goal Action Date of November 14, 2026” (opens the source at this quote in a new tab)

Special FDA designation

“The U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for the proposed use of ivonescimab” (opens the source at this quote in a new tab)

Authorization outside the United States

“Ivonescimab was approved for marketing authorization in China in May 2024.” (opens the source at this quote in a new tab)