FDA News

The Food and Drug Administration (FDA) approved a supplemental new drug application for the multikinase inhibitor lenvatinib (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma.

The FDA has granted a second breakthrough therapy designation to the combination use of lenvatinib (Lenvima) and pembrolizumab (Keytruda) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy.

The FDA has granted a breakthrough therapy designation to atezolizumab (Tecentriq) for use in combination with bevacizumab (Avastin) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma (HCC).

The FDA announced today that it has approved the first biosimilar for the treatment of multiple types of cancer.

The FDA has approved a new agent for the treatment of severe hepatic veno-occlusive disease, a rare but often fatal complication in patients who receive chemotherapy and hematopoietic stem cell transplantation.

The FDA has granted an accelerated approval for Tagrisso (osimertinib) to treat patients with advanced non–small cell lung cancer (NSCLC) positive the EGFR T790M mutation and whose disease worsened following a prior EGFR TKI.