FDA NDA Filed for Zipalertinib Combo in Rare Lung Cancer
A new drug application has been initiated for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC under the FDA's Real-Time Oncology Review program.
A new drug application has been submitted for zipalertinib in combination with chemotherapy as a first-line treatment for non-small cell lung cancer driven by EGFR exon 20 insertion mutations, with the filing seeking review under the FDA's Real-Time Oncology Review program, which is designed to accelerate access to promising cancer therapies.
The submission is supported by data from the Phase 3 REZILIENT3 clinical trial, in which the zipalertinib combination regimen produced the longest median progression-free survival observed to date among patients in the first-line EGFR exon 20 insertion NSCLC setting, a patient population historically associated with limited treatment options and poor outcomes on standard therapies.
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EGFR exon 20 insertion mutations represent a distinct and difficult-to-treat molecular subtype of NSCLC. Unlike more common EGFR mutations, exon 20 insertions have generally shown resistance to earlier-generation EGFR inhibitors, making the development of targeted agents in this space a significant clinical priority.
The FDA's Real-Time Oncology Review pathway allows the agency to begin evaluating key portions of a drug application before the formal submission is complete, potentially shortening the time to a regulatory decision and, if approved, to patient access. The program is reserved for therapies that show substantial improvement over available treatments.
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