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Updated current and draft version of the database with FDA oncology approvals from April 2025.

A few pull requests were completed for the work in progress version of the database:

Database content updates

Revised entries:

  • (FDA) Pembrolizumab in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with HER2-positive gastric adenocarcinoma received traditional FDA approval after previously receiving accelerated approval. The FDA’s product label from March 19th incorrectly still labeled this approval as an accelerated approval, they withdrew it and uploaded a corrected label on April 21st.
  • (FDA) Nivolumab in combination with ipilimumab for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer received regular approval from the FDA after receiving accelerated approval in July 2018.
  • (FDA) Nivolumab as a single agent for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy received regular approval from the FDA after receiving accelerated approval in July 2018.
  • (FDA) Larotrectinib for the treatment of adult and pediatric patients with solid tumors with NTRK fusions received regular approval from the FDA, after receiving accelerated approval in November 2018.