Avastin

Avastin (bevacizumab) received a new indication approval on May 29, 2020, for Hepatocellular Carcinoma (HCC) in combination with atezolizumab for unresectable or metastatic HCC in patients who have not received prior systemic therapy. This approval was granted under Application Number 125085Orig1s332. Bevacizumab itself was approved on February 26, 2004, and atezolizumab on May 18, 2016. The drug received Orphan Drug Designation on January 08, 2018, and Breakthrough Therapy Designation on July 13, 2018.

In efficacy studies, the atezolizumab/bevacizumab arm demonstrated a Median Progression-Free Survival (PFS) of 6.8 months, compared to 4.3 months for the sorafenib arm. The Overall Survival (OS) Hazard Ratio was 0.58 (95% CI: 0.42, 0.79; p-value: 0.0006). The Median OS for the sorafenib arm was 13.2 months. In another assessment, the Median Overall Survival (OS) in the Bv + RT/T arm was 18.3 months, compared to 27 months in the RT/T arm, with an OS Hazard Ratio of 1.23 (95% CI: 0.72, 2.09).

Safety findings indicate that 38% of patients experienced serious adverse reactions. The incidence of Grade ≥ 3 AESIs and SAEs, as well as AEs leading to withdrawal, was higher in some study arms. The ADA-positive rate was 28%, with 20% at Week 6. Clearance of atezolizumab in the ADA-positive subgroup was 49%. Grade 3-4 VTE occurred in 11% of patients.