​Hepatocellular carcinoma (HCC), the most common type of primary liver cancer, is a challenging condition to treat, with reported five-year survival rates ranging from 30% to 50%. Recently, the FDA approved cabozantinib (Cabometyx®, Exelixis, Inc.) as second-line treatment for patients with HCC previously treated with sorafenib. Thomas A. Abrams, MD, Assistant Professor of Medicine at Harvard Medical School, spoke with i3 Health about cabozantinib's approval and about the various options now ava...

The FDA has now approved cabozantinib (Cabometyx®, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) previously treated with sorafenib. The approval was based on CELESTIAL (NCT01908426), a double-blind, multicenter trial of 707 patients with HCC randomized in a 2:1 ratio to receive cabozantinib 60 mg once daily or matching placebo. Eligible patients had been previously treated with sorafenib, had disease progression following at least one systemic treatment for HCC, and could have...

The FDA has now approved olaparib (Lynparza®, AstraZeneca Pharmaceuticals LP) for maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer experiencing complete or partial response to first-line platinum-based chemotherapy. Patients are to be selected for therapy using an FDA-approved companion diagnostic, the BRACAnalysis CDx® test (Myriad Genetic Laboratories, Inc.). The ...

Trastuzumab-pkrb (Herzuma ® , Celltrion Inc.) has recently been FDA-approved to treat human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer. Trastuzumab-pkrb is a biosimilar to trastuzumab (Herceptin ® , Genentech Inc.). Biosimilars—biological agents made from living organisms—are almost identical to another biological agent that has already been FDA-approved, known as the reference drug. Biosimilars and their reference drugs may differ in production and composition; howev...

After granting Priority Review, the FDA has approved atezolizumab (Tecentriq®, Genentech, Inc.), a monoclonal antibody, to be used in combination with carboplatin/paclitaxel/bevacizumab (CPB) for patients with previously untreated metastatic nonsquamous, non-small cell lung cancer (NSCLC) without EGFR or ALK tumor mutations. The approval was based on the open-label, three-arm IMpower150 trial (NCT02366143), for which patients were randomized 1:1:1 to a regimen of atezolizumab plus CPB, a regimen...