EGFR+ Lung Cancer

The FDA designates iza-bren as a breakthrough therapy for advanced EGFR-mutant NSCLC, promising improved outcomes for patients with limited options.

FDA fast-tracks DB-1310, a novel HER3-targeting ADC, offering hope for advanced NSCLC patients with unmet treatment needs.

Osimertinib plus chemotherapy significantly improves overall survival in EGFRm NSCLC, signaling a new standard of care.

FDA accelerates approval of datopotamab deruxtecan for advanced EGFR-mutated NSCLC, offering new hope for previously treated patients.

Zipalertinib shows promising efficacy and safety for advanced NSCLC with EGFR exon 20 mutations, offering a much-needed oral treatment option.

A prophylactic dermatologic regimen significantly reduced skin side effects and improved quality of life for NSCLC patients on amivantamab/lazertinib.

Patritumab deruxtecan did not improve overall survival compared to chemotherapy in EGFR-mutated NSCLC, despite showing PFS and ORR benefits previously.

Amivantamab plus chemotherapy significantly improved PFS and ORR in EGFR-mutated NSCLC patients resistant to osimertinib, regardless of resistance mechanisms.

The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with the agency.

During a live event, Xiuning Le, MD, PhD, discussed clinical trials of supportive care for infusion reaction and skin rash with amivantamab in EGFR-mutated lung cancer.

During a live event, Xiuning Le, MD, PhD, discussed updated intracranial efficacy, overall survival, and safety of amivantamab plus lazertinib in patients with EGFR-mutated non–small cell lung cancer.

Final overall survival data from the MARIPOSA trial show that amivantamab and lazertinib improves survival vs osimertinib in EGFR-mutated NSCLC.

During a Community Case Forum event in partnership with the Texas Society of Clinical Oncology, Natalie Vokes, MD, discussed trials of targeted agents for EGFR-mutant lung cancer.

The phase 2b REZILIENT1 trial of zipalertinib in EGFR+ non–small cell lung cancer met its overall response rate primary end point with a consistent safety profile.

A pooled analysis of sunvozertinib in EGFR TKI-resistant NSCLC showed promising antitumor activity and favorable safety, achieving a 27.5% objective response rate.

During a Community Case Forum event in partnership with the Medical Oncology Association of Southern California, Edward S. Kim, MD, MBA, discussed the FLAURA2 and MARIPOSA trials of newer regimens for EGFR-positive lung cancer.

During a Case-Based Roundtable® event, Joshua K. Sabari, MD, continued discussion of key outcomes from the MARIPOSA trial and toxicity management in patients with EGFR-mutated non–small cell lung cancer in the second article of a 2-part series.

The FDA granted priority review to datopotamab deruxtecan in advanced EGFR-mutated NSCLC after prior therapies, with a decision expected by July 12, 2025.

The FDA granted priority review to sunvozertinib for the treatment of advanced NSCLC with EGFR exon 20 mutations, based on promising efficacy and safety data from the WU-KONG1 trial.

The MARIPOSA study showed that the combination of amivantamab and lazertinib significantly improved overall survival over osimertinib in EGFR-mutated NSCLC.

During a Case-Based Roundtable® event, Joshua K. Sabari, MD, discussed the mechanism of action of amivantamab and the MARIPOSA trial in patients with EGFR-mutated non–small cell lung cancer in the first article of a 2-part series.

The FDA issued a complete response letter for the BLA submission of subcutaneous amivantamab for EGFR-mutated NSCLC, citing manufacturing inspection issues, but confirming no need for additional clinical trials.

The FDA granted breakthrough therapy status to sacituzumab tirumotecan in EGFR-mutated advanced non–small cell lung cancer.

A new BLA for datopotamab deruxtecan aims for FDA accelerated approval to treat EGFR-mutated NSCLC based on data from multiple TROPION trials, following FDA feedback.

The approval of amivantamab plus carboplatin and pemetrexed is supported by data from the phase 3 MARIPOSA-2 trial.