AstraZeneca PLC’s (LON:AZN) antibody Imfinzi and a potential new combination with tremelimumab are to be fast-tracked as a way to treat advanced liver cancer.
The US Food and Drug Administration has granted Orphan Drug Designation (ODD) to both Imfinzi on its own and the new combination, a status granted to new drugs for critical diseases that affect less than 200,000 people.
READ: Mixed picture for UK pharma as AstraZeneca ‘top pick’ at Credit Suisse while GSK knocked by Barclays downgrade
ODD status gives tax breaks, reduced fees and a 7-year period of marketing exclusivity for the drug concerned.
HCC/liver cancer is the third leading cause of cancer death worldwide and only 13% of patients at an advanced stage are alive five years after diagnosis.
The FTSE 100-listed pharma giant is currently carrying out phase III trials of Imfinzi both as a single treatment for liver cancer and in combination with tremelimumab.
Imfinzi is already approved to treat advanced lung cancer and bladder cancer in 54 and 11 countries respectively, including the US, but has not yet been approved for liver cancer anywhere either solely or in a combination.
Prostate cancer drug granted priority review
In a separate announcement, the company said its blockbuster targeted therapy drug Lynparza had been a granted priority review in the US as a possible treatment for prostate cancer.
The priority review follows a phase III trial that showed Lynparza reduced the risk of disease progression or death in men suffering the disease by 66%.
Lynparza, a PARP inhibitor, is currently approved in 65 countries to treat women with certain types of ovarian cancer.
PARP – or poly-ADP ribose polymerase – is a protein that helps damaged cells to recover.
Taking a PARP inhibitor stops it from repairing cancer cells, which then eventually die.
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