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Silevertinib Drives CNS Responses in First-Line NSCLC With Non-Classical EGFR Mutations

OncLive’s November Roundup of Key FDA Approvals in Oncology: 10 Decisions to Know
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The top 5 OncLive TV videos of the week cover insights in ovarian cancer, lung cancer, urothelial cancer, and prostate cancer.

The FDA approved a new option in resectable gastric cancer, and a new agent is under priority review in mantle cell lymphoma.

Durvalumab administered with chemoradiotherapy rather than afterwards generated no significant improvement in PFS, OS, or ORR for patients with NSCLC.

Ticiana Leal, MD, discusses clinical considerations surrounding the diagnosis of LEMS in patients with lung cancer.

Subcutaneous toripalimab generated non-inferior efficacy and safety outcomes vs the IV formulation in recurrent/metastatic non squamous NSCLC.

Sacituzumab tirumotecan plus pembrolizumab improved PFS as first-line treatment in PD-L1–positive advanced NSCLC.

Panelists discuss how novel agents and emerging strategies may further optimize sequencing and outcomes for EGFR PACC-mutated NSCLC.

Panelists discuss how the FURTHER trial demonstrated firmonertinib’s efficacy and safety in patients with PACC mutations.

The top 5 OncLive TV videos of the week cover insights in ovarian cancer, lung cancer, urothelial cancer, and prostate cancer.

The FDA approved 5 therapeutic options spanning lung cancer, urothelial cancer, NF1-associated PNs, and AL amyloidosis.

A rolling NDA submission for zipalertinib in NSCLC with EGFR exon 20 insertion mutations who received prior chemotherapy has been initiated.

Will the FDA approve zidesamtinib for ROS1-positive advanced non–small cell lung cancer after a prior TKI?

The FDA OKs the Oncomine Dx Target Test to identify patients with HER2 TKD–mutant NSCLC eligible for sevabertinib, enabling targeted treatment selection.

The FDA approved sevabertinib for previously treated, nonsquamous non–small cell lung cancer with HER2 TKD activating mutations.

The FDA has granted traditional approval to tarlatamab-dlle (Imdelltra) for the treatment of select patients with ES-SCLC.

Benjamin Herzberg, MD discusses challenges and evolving strategies for managing high-risk NSCLC subsets, underscoring the value of genomic testing.

Benjamin Herzberg, MD, discusses the management challenges associated with STK11/KEAP1-mutated tumors, SMARCA4-deficient undifferentiated tumors, and NUT carcinoma.

Erminia Massarelli, MD, PhD, MS, discusses the clinical presentation and management of Lambert–Eaton myasthenic syndrome in the context of small cell lung cancer.

Alexander Drilon, MD, summarized approaches to TKI selection in NSCLC displaying oncogenic driver alterations for both TKI-pretreated and -naive patient populations.

ZEN-3694 obtained orphan drug designation from the FDA for the treatment of NUT carcinoma.

Joshua K. Sabari, MD, discusses the FDA approval of lurbinectedin plus atezolizumab as first-line maintenance therapy in extensive-stage SCLC.

Panelists discuss how financial toxicity and cost-effectiveness analyses highlight the importance of appropriate patient selection for perioperative immunotherapy, while emphasizing that multidisciplinary care and patient involvement remain essential for optimal outcomes.

Gregory J. Riely, MD, PhD, discusses targeted approaches for BRAF V600E, MET exon 14, and KRAS G12C mutations in metastatic NSCLC.

Neladalkib elicited responses and was active in the CNS in TKI-pretreated patients with advanced ALK-positive NSCLC, including lorlatinib-naive patients.

Panelists discuss how firmonertinib shows promise as a next-generation TKI with broad EGFR activity and favorable tolerability.
















































































