New Monotherapy Approved for HCC Patients

FDA Removes Boxed Warning With Drug’s Fifth Approval

The FDA has approved ramucirumab (Cyramza, Eli Lilly) as a single agent for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) and have previously been treated with sorafenib.

The approval was based on results from REACH-2, the first positive phase 3 HCC trial in a biomarker-selected patient population. AFP is a prognostic biomarker that can be determined via a blood test, which doctors can then use to determine if ramucirumab treatment would be appropriate.

HCC is the most common form of liver cancer, itself the fourth-leading cause of cancer-related deaths worldwide. Close to half of all patients with advanced HCC have high levels of AFP, and are among those with the poorest prognosis. Prior to ramucirumab’s approval, there were no treatment options specifically aimed at patients with increased AFP concentrations.

In REACH-2, treatment with ramucirumab significantly improved patients’ overall survival (OS) compared with placebo (median OS = 8.5 months vs. 7.3 months). Median progression-free survival (PFS) was also improved with ramucirumab (2.8 months vs. 1.6 months for placebo).

Ramucirumab’s fifth approval brought about the FDA’s removal of the boxed warning from its label. The warning was to indicate potential hemorrhage, gastrointestinal perforation, and impaired wound healing.

Ramucirumab could also be approved to treat patients with metastatic non–small-cell lung cancer whose tumors have activating EGFR mutations. The drug has already demonstrated a statistically significant improvement in the time patients lived without their cancer growing or spreading after beginning treatment.

Source: BioSpace, May 14, 2019