EGFR+ Lung Cancer

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.

Zipalertinib appeared safe and effective in the treatment of heavily pretreated patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations who progressed on or after amivantamab.

Pretreatment with dexamethasone significantly reduced infusion-related reactions in patients receiving amivantamab for advanced lung cancer, according to findings from the SKIPPirr study.

Byoung Chul Cho, MD, PhD, discussed findings from cohort C of the CHYRSALIS-2 study exploring amivantamab plus lazertinib in patients with non–small cell lung cancer with uncommon EGFR mutations.

Lazertinib and amivantamab as a first-line treatment for patients with locally advanced or metastatic non–small cell lung cancer with specific EGFR mutations demonstrated superior efficacy compared with standard treatment.

Suresh S. Ramalingam, MD, discussed the practice-changing findings and implications of the phase 3 LAURA study investigating osimertinib for the treatment of patients with EGFR-mutated non–small cell lung cancer.

Nicolas Girard, MD, PhD, discussed findings from the PALOMA-2 study investigating subcutaneous vs intravenous amivantamab plus lazertinib for previously untreated, EGFR-mutant non–small cell lung cancer.

Findings from the MARIPOSA trial showed that amivantamab plus lazertinib were superior to osimertinib for the treatment of EGFR-mutant non–small cell lung cancer.

Patritumab deruxtecan has been issued a complete response letter to its biologics license application for the treatment for patients with advanced non-small cell lung cancer with EGFR mutations after prior treatment with 2 or more lines of therapy.

A biologics license application for subcutaneous amivantamab combined with recombinant human hyaluronidase has been submitted to the FDA for NSCLC indications.

Osimertinib given after chemoradiation in patients with advanced non–small cell lung cancer harboring a EGFR mutation showed significant benefits.

During a Case-Based Roundtable® event, Misako Nagasaka, MD, discussed treatment for a patient with non–small cell lung cancer and an EGFR exon 20 insertion.

During a Case-Based Roundtable® event, Joshua Sabari, MD, led a discussion on the need for next-generation sequencing to determine treatment in patients with EGFR-positive advanced non–small cell lung cancer in the first article of a 2-part series.

Sunvozertinib was granted breakthrough therapy designation by the FDA for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring an EGFR exon 20 insertion mutation.

Though osimertinib is the preferred frontline approach to treatment for those with non-small cell lung cancer with classic EGFR mutations, acquired resistance mechanisms invariably develop.

According to a subset analysis of the phase 3 MARIPOSA trial, dose interruptions during the course of amivantamab and lazertinib treatment were still effective in EGFR-mutant non-small cell lung cancer.

Amivantamab plus carboplatin and pemetrexed is now an approved first-line treatment for patients with EGFR exon 20 insertion mutation-positive non-small cell lung cancer.

Osimertinib shows significant progression-free survival improvement in stage III EGFR-mutated non-small cell lung cancer post-chemoradiotherapy, marking a major advance in treatment options for this patient population.

The FDA has approved the combination of osimertinib plus chemotherapy for the treatment of EGFR-mutated non-small cell lung cancer.

Participants in virtual events discussed the key issue of whether to initiate therapy immediately or wait for test results that could show the best approach in patients with advanced lung cancer.

The FLAURA2 study found that osimertinib with platinum-pemetrexed was more effective than osimertinib monotherapy in preventing central nervous system progression or death in patients with EGFR-mutated advanced non–small cell lung cancer.

In an interview, Martin F. Dietrich, MD, PhD, discussed his observations on the latest and upcoming trials that target biomarkers in earlier-stage non–small lung cancer.

During a Targeted Oncology™ Case-Based Roundtable™ event, Balazs Halmos, MD, discussed with participants how they interpret the ADAURA trial and the approach to adjuvant targeted therapy in non–small cell lung cancer This is the second of two articles based on this event.

In an interview with Targeted Oncology, Jonathan W. Riess, MD, discussed the ever-changing EGFR-mutated lung cancer treatment landscape, highlighting several agents that are currently under development.

During a Targeted Oncology™ Case-Based Roundtable™ event, Balazs Halmos, MD, discussed with participants how they would approach the case of a patient with T3N0 lung adenocarcinoma of stage IIB. This is the first of 2 articles based on this event.

The FDA is considering 2 applications for amivantamab plus lazertinib as a first-line treatment for EGFR-mutated non–small cell lung cancer, based on the phase 3 MARIPOSA study.

Anlotinib, a novel multi-targeting tyrosine kinase inhibitor, and icotinib, a first-generation EGFR TKI, demonstrated efficacy and tolerability in the first line for the treatment of patients with EGFR-mutated advanced non–small cell lung cancer.