The Food and Drug Administration (FDA) has approved Cyramza (ramucirumab; Lilly) for use as a single agent in the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400ng/mL and have been treated with sorafenib.
The approval was based on data from the REACH-2 study, a double-blind, placebo-controlled study that evaluated the efficacy of Cyramza in patients with advanced HCC with AFP ≥400ng/mL who had disease progression on or after prior sorafenib therapy or who are intolerant to sorafenib (N=292). The primary efficacy outcome measure was overall survival (OS); progression-free survival (PFS) and objective response rate (ORR) were included as additional outcome measures.
Results showed Cyramza plus best supportive care (BSC) was associated with a statistically significant benefit in OS when compared with placebo plus BSC (hazard ratio [HR] 0.71, 95% CI: 0.53-0.95; P =.020). In addition, a statistically significant improvement in PFS was also observed with Cyramza vs placebo (HR 0.45, 95% CI: 0.34-0.60; P <.0001). With regard to safety, the most common adverse reactions in HCC patients treated with Cyramza were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, ascites, thrombocytopenia, hypoalbuminemia, and hyponatremia.
Based on additional safety data obtained through this new approval, the FDA has removed the Boxed Warning from the labeling for Cyramza. Information and recommendations on hemorrhage risk, gastrointestinal perforations, and impaired wound healing continues to be available in the Warnings and Precautions section.
Cyramza injection is available as a 10mg/mL preservative-free solution supplied in single-dose vials.
For more information visit lilly.com.