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AstraZeneca drugs win US FDA orphan-drug tag for liver cancer

AstraZeneca PLC's medicines Imfinzi and tremelimumab received the U.S. Food and Drug Administration's orphan-drug designation to treat patients with hepatocellular carcinoma.

HCC is the most common type of liver cancer and often develops in people with existing liver diseases, such as chronic hepatitis B and C.

The U.K.-based pharmaceutical giant is evaluating Imfinzi, both as a stand-alone therapy and in combination with tremelimumab, to treat patients with advanced HCC who have not received any prior therapy and are not eligible for locoregional therapy, which is localized to the liver. José Baselga, the company's executive vice president of oncology R&D, said results from an ongoing phase 3 trial, dubbed Himalaya, are expected later this year.

Sorafenib is marketed by Germany's Bayer AG as Nexavar and is the standard of care for HCC patients.

The U.S. FDA grants orphan-drug designation to therapies that can treat, diagnose or prevent rare disorders that affect fewer than 200,000 people in the country. Such treatments then receive incentives, such as market exclusivity, if approved.

Imfinzi, or durvalumab, is currently not approved to treat HCC in any country as a monotherapy or in combination with tremelimumab.

Imfinzi is already approved for treating certain patients with non-small cell lung cancer in over 54 countries, including the U.S., EU, China and Japan. The medicine is also approved in 11 countries, including the U.S., to treat patients with advanced bladder cancer.

In October 2019, a combination of Imfinzi and tremelimumab was found to delay the progression of advanced lung cancer in patients who had been previously treated with other therapies in a late-stage clinical trial called Poseidon.