Roche's Tecentriq + Avastin Receives the US FDA's Approval for Unresectable or Metastatic Hepatocellular Carcinoma
Shots:
- The approval is based on P-III IMbrave150 study assessing Tecentriq (IV- 1200mg on day 1 of each 21-day cycle) and Avastin (IV- 15 mg/kg on day 1 of each 21-day cycle) vs sorafenib (400mg bid- on days 1-21 of each 21-day cycle) in 501 people in a ratio (2:1) with unresectable/ metastatic HCC prior not treated with systemic therapy
- Results: 42% reduction in risk of death- 41% reduction in disease worsening- results were published in NEJM on May 14- 2020. The US FDA has approved the application under Project Orbis initiative and Real-Time Oncology Review pilot program helping to bring the new treatment option rapidly to patients in the US and ROW
- Roche has an extensive development program for Tecentriq- including multiple ongoing and planned Phase III studies for lung- genitourinary- skin- breast- gastrointestinal- gynecological- and head and neck cancers. This includes studies evaluating Tecentriq both as monothx. and in combination with other therapies
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