Caroline Seymour

The FDA approved the FoundationOne Liquid CDx to identify patients with metastatic non–small cell lung cancer (mNSCLC) with MET exon 14 skipping alterations who may be eligible for tepotinib (Tepmetko; EMD Serono).

Should the FDA require that new trial design proposals for perioperative regimens for resectable non–small cell lung cancer (NSCLC) include adequate within trial assessment?

The FDA has granted 2 breakthrough therapy designations to trastuzumab deruxtecan for the treatment of patients with unresectable or metastatic HER2-positive solid tumors that have progressed after prior treatment and who have no satisfactory alternative treatment options, and for those with HER2-positive metastatic colorectal cancer who have received at least 2 prior lines of therapy.

The phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 trial found the addition of tumor treating fields (TTFields) to paclitaxel did not provide a statistically significant improvement in overall survival (OS) vs paclitaxel alone for patients with platinum-resistant ovarian cancer, failing to meet its primary end point.

Epcoritamab has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for B-cell Lymphomas in the third- or later-line setting for the treatment of patients with diffuse large B-cell lymphoma.

Iptacopan elicited improved hemoglobin levels measuring at least 2 g/dL higher vs baseline, leading to transfusion independence after 24 weeks in approximately 92.2% of patients with complement inhibitor–naïve paroxysmal nocturnal hemoglobinuria.