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FDA Grants Durvalumab Plus Tremelimumab Orphan Drug Status in HCC

Gina Columbus
Published: Tuesday, Jan 21, 2020

Jose Baselga, MD, PhD, executive vice president, Oncology R&D, AstraZenec

José Baselga, MD, PhD

The FDA has granted an orphan drug designation to durvalumab (Imfinzi) and tremelimumab for the treatment of patients with hepatocellular carcinoma (HCC).1

The combination is being investigated in the phase III HIMALAYA trial (NCT03298451) of patients with unresectable, advanced HCC who have not previously received systemic treatment and are ineligible for locoregional therapy. The study is also evaluating single-agent durvalumab in this patient population.

“Many patients with liver cancer are diagnosed and treated only after the disease is advanced, and there is an urgent need for new effective and tolerable treatments,” José Baselga, MD, PhD, executive vice president, Oncology R&D, AstraZeneca, the developer of the PD-1 and CTLA-4 inhibitors, stated in a press release. “We are eager to bring new potential options to these patients and look forward to the results of our ongoing phase III HIMALAYA trial later this year.”

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