Lung Cancer Treatment Submission Has Been Initiated
Patients with a specific type of lung cancer may have a new potential therapy option under federal review.
Updated on Oct. 2, 2026 in Cancer
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Cullinan Therapeutics has begun the New Drug Application process for the medication zipalertinib in combination with chemotherapy to treat certain lung cancers. The FDA will evaluate this therapy through its Real-Time Oncology Review program.
Why it matters
This application aims to provide a new treatment approach for patients with locally advanced or metastatic non-small cell lung cancer characterized by EGFR exon 20 insertion mutations. By utilizing a combination therapy, the goal is to improve clinical outcomes compared to standard chemotherapy alone.
The submission is grounded in findings from the Phase 3 REZILIENT3 trial, which demonstrated that zipalertinib combined with chemotherapy improved median progression-free survival compared to chemotherapy alone. This trial specifically enrolled patients with previously untreated lung cancer.
The players
Cullinan Therapeutics
A biopharmaceutical company focused on developing targeted oncology therapies, including zipalertinib for lung cancer.
FDA
The United States agency responsible for regulating pharmaceuticals and ensuring the safety and efficacy of medical treatments.
The details
The treatment targets non-small cell lung cancer harboring EGFR exon 20 insertion mutations, a subset of lung cancer that can be resistant to traditional therapies. Zipalertinib is designed to work in conjunction with chemotherapy to inhibit these specific genetic drivers of tumor growth. The FDA's Real-Time Oncology Review program facilitates this process by allowing developers to submit clinical trial data on a rolling basis before the formal application is finalized.
Timeline
October 1, 2026: Initiation of New Drug Application submission for the combination therapy.
Year-end 2026: Anticipated completion of the full NDA submission process.
February 27, 2027: PDUFA target action date for the zipalertinib monotherapy application.
Health Landscape
This submission utilizes the FDA Real-Time Oncology Review program, a mechanism designed to accelerate the delivery of oncology treatments to patients. It marks a shift toward more efficient regulatory pathways for therapies targeting specific genetic mutations in non-small cell lung cancer.
If you are currently managing a lung cancer diagnosis, it is worth discussing with your oncologist whether your tumor has been tested for EGFR exon 20 insertion mutations. This regulatory progress highlights the importance of genetic testing in determining which advanced treatment options might be suitable.
The takeaway
The development of combination therapies for specific genetic mutations represents a targeted shift in how non-small cell lung cancer is treated. Patients should consult their care team to ensure they have access to the latest genetic profiling, which remains the key to identifying potential eligibility for novel treatments.
What happens next
The NDA submission for the combination therapy is expected to be completed by year-end 2026, followed by the monotherapy target date on February 27, 2027.
Further reading
For broader context on current approaches to managing lung malignancies, see our latest updates on Cancer.
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