Over the past year, the U.S. Food and Drug Administration granted approval to several novel drugs and new indications for older therapeutic agents used in gastrointestinal oncology.
Cetuximab Plus Encorafenib
On September 28, 2021, cetuximab (Erbitux) was approved in combination with encorafenib (Braftovi) for the treatment of adults with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
On August 25, 2021, ivosidenib (Tibsovo) was granted approval for the treatment of adults with previously treated locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.
On May 28, 2021, the kinase inhibitor infigratinib (Truseltiq) received accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement, as detected by an FDA-approved test.
On May 20, 2021, nivolumab (Opdivo) was approved for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.
Pembrolizumab Plus Trastuzumab Plus Chemotherapy
On May 5, 2021, pembrolizumab (Keytruda) in combination with trastuzumab (Enhertu, Herceptin) plus fluoropyrimidine- and platinum-containing chemotherapy was approved for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Nivolumab Plus Chemotherapy
On April 16, 2021, nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy was approved for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
On April 6, 2021, approval was granted for a new dosage regimen for cetuximab (Erbitux) of 500 mg/m2 as a 120-minute intravenous infusion every 2 weeks for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.
Pembrolizumab Plus Chemotherapy
On March 22, 2021, pembrolizumab (Keytruda) in combination with platinum- and fluoropyrimidine-based chemotherapy was approved for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1–5 cm above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation.