Mechanism of Action: Cetuximab

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.

In this episode, Joshua K. Sabari, MD, discusses the FDA approval of amivantamab plus chemotherapy as a first-line treatment for patients with EGFR exon 20 insertion mutation-positive 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.

In season 2, episode 1 of Targeted Talks, Nagashree Seetharamu, MD, led a conversation with Luis E. Raez, MD, about the evolving treatment landscape for EGFR exon 20–mutated lung cancer.

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.