Hematology/Oncology (Cancer) Approvals & Safety Notifications | FDA

Hematology/Oncology (Cancer) Approvals & Safety Notifications | FDA

Hematology/Oncology (Cancer) Approvals & Safety Notifications

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.

2020

• Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. More Information. April 22, 2020 
• Food and Drug Administration expanded the indication of ibrutinib (IMBRUVICA, Pharmacyclics LLC) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic l