The Swiss Roche Group announced yesterday that TECENTRIQ® (atezolizumab) in combination with Avastin® (bevacizumab) has been approved by the US Food and Drug Administration (FDA) for breakthrough therapy for initial (first-line) treatment of advanced or metastatic liver Patients with cell carcinoma (HCC).
HCC is the most common type of primary karaciğer kanseri . This breakthrough therapy is based on the results of a Phase Ib study on the safety and clinical activity of TECENTRIQ combined with Avastin.
Dr. Sandra Horning, Roche’s chief medical officer and head of global product development, said: Hepatocellular carcinoma, as a malignant tumor, has limited treatment options and is the leading cause of death worldwide. Preliminary data on the treatment of this disease with TECENTRIQ and Avastin is promising. We look forward to cooperating with the health department to bring this highly promising treatment plan to patients with hepatocellular carcinoma as soon as possible.
Breakthrough Therapy Designation (BTD) aims to accelerate the development and review of new drugs for the treatment of serious or life-threatening diseases to ensure that these drugs are approved by FDA as soon as possible to benefit patients. This is not only the 22nd BTD obtained by Roche’s pharmaceutical product line, but also the 3rd BTD obtained by TECENTRIQ.
The Roche Group published data from the Phase Ib study of hepatocellular carcinoma at the American Society of Clinical Oncology (ASCO) annual meeting in June 2018. The results of the study showed that after a median follow-up of 10.3 months, remission was observed in 15 (65%) of 23 evaluable patients.
After a median follow-up of 10.3 months, the median progression-free survival (PFS), duration of remission (DOR), disease progression time (TTP), and overall survival (OS) were not reached. Of the safety-evaluable patients (n = 43), 28% (n = 12) experienced grade 3-4 treatment-related adverse events, and no treatment-related grade 5 adverse events were observed.
Roche has provided additional data in accordance with FDA requirements, and has been granted a breakthrough therapy qualification. After obtaining updated data from follow-up trials, Roche will publish the research results at a future medical conference.
