Three FDA Approvals and Two Priority Reviews

The FDA approved imlunestrant plus abemaciclib in breast cancer and photodynamic therapy in skin cancer, and more.

The FDA approved pirtobrutinib for untreated chronic lymphocytic leukemia, granted priority review to elinzanetant for breast cancer hot flashes, and more.

TRE-515 earned fast track status in combination with KRAS inhibitors for G12C-mutated NSCLC after anti–PD-(L)1 therapy and platinum-based chemotherapy.

An NDA for zipalertinib in EGFR exon 20 insertion–positive NSCLC is being supported by phase 3 REZILIENT3 data.

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Estelamari Rodriguez, MD, MPH, discusses the rationale, design, and practice implications of the phase 3 RELATIVITY-1093 trial in nonsquamous NSCLC.

Plinabulin plus docetaxel received fast track designation for pretreated nonsquamous NSCLC without actionable genomic alterations.