Ivonescimab for EGFR-mutated lung cancer: FDA decision status
Summit Therapeutics has asked the US FDA to approve ivonescimab with chemotherapy for advanced EGFR-mutated non-squamous non-small cell lung cancer after EGFR TKI treatment.
Status: pending FDA decision
FDA goal date (PDUFA): . Ivonescimab is not yet approved in the US.
Last checked: . The FDA may act on or before the goal date, and the date can move if the review is extended. We will update this box after the FDA acts.
Ivonescimab is not yet FDA-approved. The FDA accepted Summit's Biologics License Application in January 2026, and the goal date for a decision is 14 November 2026. Summit restated that date on 5 October 2026.
What ivonescimab is
- Ivonescimab is a bispecific antibody that blocks both PD-1 and VEGF in one molecule, given by infusion. [1]
- It was developed by Akeso. Summit Therapeutics holds the license for North and South America, Europe, the Middle East, Africa and Japan. [1]
- The pending application is a Biologics License Application (BLA), accepted by the FDA in January 2026. [1]
- Use under review: with chemotherapy, for patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after EGFR tyrosine kinase inhibitor (TKI) therapy. [1]
- It was first approved in China in May 2024. [1][2] The US brand name will be confirmed from the FDA label.
What the main trial showed
The application rests on HARMONi, a Phase 3 trial of ivonescimab plus platinum-based chemotherapy versus placebo plus chemotherapy. [1] In an updated analysis (June 2026 data), the overall survival hazard ratio was 0.76 (95% CI 0.61 to 0.95; nominal p=0.0151), with a median overall survival of 16.8 months versus 14.0 months. The earlier primary analysis from April 2025 (HR 0.79, p=0.057) was not statistically significant. [2]
Who it may be for
Adults with advanced non-squamous NSCLC that carries an EGFR mutation and has progressed after EGFR TKI treatment, as described in the application. [1] The final approved wording will come from the FDA label. The treating oncologist decides whether a patient might be a candidate.
Ivonescimab in the Gulf
On 17 October 2026 we did not find ivonescimab in the Saudi SFDA drugs list or in the Abu Dhabi DoH drug code list (release 26 September 2026). [4][5] Summit's license territory includes the Middle East. [1] We found no public Gulf filing for ivonescimab in the sources we checked.
How Gulf patients may access it
- Before a US decision: access is through clinical trials, or through a developer access program if one exists. We have not confirmed whether Summit runs one; the treating oncologist can ask Summit directly.
- After a US approval: where it is not registered locally, the treating oncologist can usually apply to the national regulator to import it for a named patient, with a prescription, a medical report and a justification. The regulator decides.
- Our role: Reserve Meds coordinates access to FDA-approved medicines. After approval, we can help families organise documents, work with the treating oncologist and arrange compliant, temperature-controlled logistics. Price: quote on request. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Ask about ivonescimab
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Frequently asked questions
Is ivonescimab approved in the US?
Not yet. The FDA goal date for a decision is 14 November 2026.
Is ivonescimab approved anywhere?
Yes. It was first approved in China in May 2024, according to Summit.
What did the HARMONi trial show?
In the updated analysis, median overall survival was 16.8 months with ivonescimab plus chemotherapy versus 14.0 months with chemotherapy alone (HR 0.76). The first analysis in 2025 did not reach statistical significance.
Who is the US sponsor?
Summit Therapeutics, which licensed ivonescimab from Akeso. Summit's territory also includes the Middle East.
What does it cost?
Quote on request. We do not publish prices. Your coordination fee is quoted in writing for your case before you commit.
Sources
- Summit Therapeutics, FDA acceptance of the ivonescimab BLA, 29 Jan 2026 (SEC Form 8-K exhibit) (accessed 17 Oct 2026)
- Summit Therapeutics, HARMONi overall survival update at WCLC 2026, 15 Sep 2026 (SEC Form 8-K exhibit) (accessed 17 Oct 2026)
- Summit Therapeutics, press release of 5 Oct 2026 restating the 14 Nov 2026 PDUFA date (accessed 17 Oct 2026)
- Saudi Food and Drug Authority, Drugs List (ivonescimab not found; checked 17 Oct 2026)
- Abu Dhabi DoH drug code list, release 26 Sep 2026 (ivonescimab not found; checked 17 Oct 2026)
This page is general information, not medical advice. Treatment decisions belong to the patient's own physician and the relevant regulator. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner.
Reviewed by the Reserve Meds clinical operations team. Last reviewed . Editorial standards.
Related: All pending FDA decisions · US-approved, not yet registered in the Gulf · Access guides