# Ivonescimab + platinum-doublet chemotherapy PDUFA Event: EGFR-mutated non-squamous non-small cell lung cancer after EGFR TKI therapy

Canonical URL: https://biopharmsignal.com/pdufa-calendar/SMMT/ivonescimab-chemotherapy-egfr-mutated-nsclc

Ticker: SMMT

Company: Summit Therapeutics

Event date: 2026-11-14

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

FDA decision expected. FDA assigned a November 14, 2026 PDUFA goal action date to the ivonescimab combination BLA.

## Event Timeline

### November 14, 2026 — FDA decision expected

FDA assigned a November 14, 2026 PDUFA goal action date to the ivonescimab combination BLA.

[Summit — BLA acceptance and PDUFA date](https://www.smmttx.com/news/press-releases/news-details/2026/Summit-Therapeutics-Announces-U-S--FDA-Acceptance-of-Biologics-License-Application-BLA-Seeking-Approval-for-Ivonescimab-in-Combination-with-Chemotherapy-in-Treatment-of-Patients-with-EGFRm-NSCLC-Post-TKI-Therapy/default.aspx)

### January 29, 2026 — FDA accepted the BLA for filing

FDA accepted the application based on the global Phase 3 HARMONi study in EGFR-mutated locally advanced or metastatic non-squamous NSCLC after third-generation EGFR TKI therapy.

[Summit — BLA acceptance](https://www.smmttx.com/news/press-releases/news-details/2026/Summit-Therapeutics-Announces-U-S--FDA-Acceptance-of-Biologics-License-Application-BLA-Seeking-Approval-for-Ivonescimab-in-Combination-with-Chemotherapy-in-Treatment-of-Patients-with-EGFRm-NSCLC-Post-TKI-Therapy/default.aspx)

### September 8, 2025 — Detailed HARMONi results were presented

Ivonescimab plus chemotherapy reduced the risk of progression or death versus chemotherapy alone, with a progression-free-survival hazard ratio of 0.52 at the prespecified primary analysis.

[Summit — Detailed global Phase 3 HARMONi results](https://smmttx.com/news/press-releases/news-details/2025/Longer-Term-Follow-Up-of-Western-Patients-Showed-Improving-Favorable-Trend-in-Overall-Survival-in-Global-Phase-III-HARMONi-Clinical-Trial-for-Ivonescimab-Plus-Chemotherapy-in-2L-EGFRm-NSCLC/default.aspx)

### October 3, 2024 — FDA granted Fast Track designation

FDA granted Fast Track designation for ivonescimab plus platinum-based chemotherapy in the post-EGFR-TKI EGFR-mutated NSCLC setting.

[Summit — Fast Track designation and HARMONi enrollment](https://www.smmttx.com/wp-content/uploads/2024/10/2024_PR_1003_HARMONi-Enrollment-Completion-_-FINAL-1.pdf)

### May 4, 2023 — Phase 3 HARMONi study started

The pivotal trial began evaluating ivonescimab plus chemotherapy versus placebo plus chemotherapy in EGFR-mutated non-small-cell lung cancer after EGFR tyrosine kinase inhibitor therapy.

[ClinicalTrials.gov — HARMONi study record (NCT06396065)](https://clinicaltrials.gov/study/NCT06396065)

## Regulatory Designations

- Fast Track FDA: [Summit — FDA Fast Track designation for the HARMONi setting](https://www.smmttx.com/wp-content/uploads/2024/10/2024_PR_1003_HARMONi-Enrollment-Completion-_-FINAL-1.pdf)

## Related Pages

- SMMT PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/SMMT.md

- SMMT company profile: https://biopharmsignal.com/company/SMMT.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2021-05-18 — Summit Therapeutics Announces Preclinical Candidate and Associated CARB-X Funding Support for the Treatment of Infections Caused by Carbapenem-Resistant Enterobacteriaceae, a CDC Urgent Threat and WHO Critical Priority: https://biopharmsignal.com/news/SMMT/summit-therapeutics-announces-preclinical-candidate-and-associated-carb-x-fundin-49a26b67.md

- 2021-05-17 — Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2021: https://biopharmsignal.com/news/SMMT/summit-therapeutics-reports-financial-results-and-operational-progress-for-the-f-ffbe4e0b.md

- 2021-05-12 — Summit Therapeutics Announces Closing of $75 Million Rights Offering: https://biopharmsignal.com/news/SMMT/summit-therapeutics-announces-closing-of-75-million-rights-offering-883ec93f.md

- 2021-05-06 — Summit Therapeutics Publishes Scientific Updates to Corporate Website: https://biopharmsignal.com/news/SMMT/summit-therapeutics-publishes-scientific-updates-to-corporate-website-794c7590.md

- 2021-05-05 — Summit Therapeutics’ Rights Offering Nearing Expiration Date; Robert W. Duggan Declares Intention to Fully Oversubscribe in the Rights Offering: https://biopharmsignal.com/news/SMMT/summit-therapeutics-rights-offering-nearing-expiration-date-robert-w-duggan-decl-cbdf96f2.md