FDA Approvals – Apr 2021

Several molecules and indications were approved in April 2021 by FDA. Among the key approvals are the following:

• Accelerated approval was granted to loncastuximab tesirine-lpyl, a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
• Accelerated approval was granted to dostarlimab-gxly for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen.
• Nivolumab was approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
• Accelerated approval was granted to sacituzumab govitecan for advanced urothelial cancer.
• Sacituzumab govitecan was approved for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
• New dosage regimen of 500 mg/m² as a 120-minute intravenous infusion every two weeks (Q2W) was approved for cetuximab for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN).