Oncology

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Based on results from the phase 2 KEYNOTE-158, KEYNOTE-164, and KEYNOTE-051 trials, the FDA has given full approval to pembrolizumab for patients with microsatellite instability-high or mismatch repair deficient solid tumors.
FDA Gives Full Approval to Pembrolizumab in dMMR/MSI-H Solid Tumors

March 29th 2023

Based on results from the phase 2 KEYNOTE-158, KEYNOTE-164, and KEYNOTE-051 trials, the FDA has given full approval to pembrolizumab for patients with microsatellite instability-high or mismatch repair deficient solid tumors.

Data from a prospective pilot study indicate that circulating tumor DNA may be a valuable prognostic biomarker in early-stage follicular lymphoma.
Basal ctDNA May Predict Treatment Outcomes in Follicular Lymphoma

March 9th 2023

The safety profile of fam-trastuzumab deruxtecan-nxki for managing HER2-expressing tumors in the DESTINY-PanTumor02 trial appears consistent with previously reported findings on the agent.
Fam-Trastuzumab Deruxtecan-nxki Yields Durable Responses in HER2+ Tumors

March 7th 2023

Findings from the phase 3 DeFi trial support the new drug application for nirogacestat as a treatment for adults with desmoid tumors.
FDA Grants Priority Review to Nirogacestat for Desmoid Tumors

February 27th 2023

Adverse effects including light sensitivity and blurred vision lead to a clinical hold on enrollment for the phase 1/2 VERA trial evaluating BLU-222 in advanced solid tumors.
FDA Pauses Trial Investigating BLU-222 in Advanced Solid Tumors

February 17th 2023

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