The past year has witnessed the U.S. Food and Drug Administration (FDA) approval of a number of novel drugs and new indications for treating patients with gastrointestinal malignancies. A summary of these approvals is provided herein.
Nivolumab plus ipilimumab: On March 10, 2020, the FDA granted accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for patients with hepatocellular carcinoma who have been previously treated with sorafenib.
Encorafenib plus cetuximab: On April 8, 2020, the FDA approved encorafenib (Braftovi) in combination with cetuximab (Erbitux) for the treatment of pretreated adult patients with metastatic colorectal cancer with a BRAF V600E mutation detected by an FDA-approved test.
Pemigatinib: On April 17, 2020, the FDA granted accelerated approval to pemigatinib (Pemazyre) for the treatment of adult patients 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.
Pembrolizumab: On April 28, 2020, the FDA granted accelerated approval to a new dosing regimen for pembrolizumab (Keytruda)—400 mg every 6 weeks—across all currently approved adult indications, in addition to the current 200 mg every 3 weeks dosing regimen.
Ripretinib: On May 15, 2020, the FDA approved ripretinib (Qinlock) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib.
Atezolizumab plus bevacizumab: On May 29, 2020, the FDA approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Nivolumab: On June 10, 2020, the FDA approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.
Pembrolizumab: On June 16, 2020, the FDA granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden–high (≥ 10 mutations/megabase) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab.
Pembrolizumab: On June 29, 2020, the FDA approved pembrolizumab for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer.
Fam-trastuzumab deruxtecan-nxki: On January 15, 2021, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.