EGFR+ NSCLC
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The study is evaluating a prophylactic dermatologic regimen in patients receiving amivantamab plus lazertinib.
The CHMP positive opinion is supported by results from the phase 3 PALOMA-3 study.
Pending discussions with the FDA, officials say there are plans to submit for regulatory approval in the second half of 2025.
Despite decades of decline, "lung cancer continues to dwarf other cancers in the number of deaths," officials said.
Dr. Liu discusses remaining questions, key considerations, and how the data might shape the field moving forward.
The approval is for the first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions.
The ORR of the external control group was 3%, while it was 36.8% in those who received amivantamab for NSCLC.
The FDA action date for its regulatory decision is anticipated during the third quarter of this year.
Dr. Liu shares his insights on the recent announcement that the phase 3 trial met its secondary endpoint of overall survival.
The phase 2 trial included patients who had advanced or metastatic NSCLC with actionable genomic alterations.
Sunvozertinib is an irreversible EGFR inhibitor that targets a wide spectrum of EGFR mutations.
For patients with NSCLC and EGFR mutations, amivantamab plus carboplatin-pemetrexed shows OS benefits versus chemo alone.
The improvement in median OS with the combination treatment is “expected to exceed one year," officials said.
The study showed there was “preliminary evidence of central nervous system-anti-tumor activity” in some patients.
The foundation's 2024 Scientific Grant Program awards mark the "largest single-year investment in its history.”
This follows the FDA’s August 2024 move to grant Priority Review for the subcutaneous amivantamab BLA.
The real-world study is the first to provide an overview of EGFR mutations and subtype prevalence in patients with NSCLC.
The real-world study was presented at the IASLC 2024 World Conference on Lung Cancer.
The approval is based on results from the phase 3 LAURA trial.
The efficacy of the combination was evaluated in the randomized, open-label, multicenter MARIPOSA-2 trial.
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