Monday , February 17 2020

AstraZeneca treatments win orphan FDA status

Bloomberg

Two AstraZeneca Plc cancer drugs received orphan status for treatment of liver cancer, a designation that may eventually speed progress to approval.
The US Food and Drug Administration (FDA) granted the special status reserved for rare conditions to Imfinzi, a lung cancer treatment, and tremelimumab, which has been tested in a combination in a variety of cancers, AstraZeneca said on Monday in a statement.
Astra has been pulling out all the stops to get new drugs to market in cancer, one of the most lucrative segments of the pharma market. Imfinzi combined with tremelimumab failed in a number of cancer tests before finally succeeding against a form of lung cancer last year.
There’s an urgent need for new treatments in liver cancer, and Astra is testing both Imfinzi and the combination with tremelimumab against liver tumors in a late-stage trial called Himalaya, according to Jose Baselga, the company’s head of cancer research.
Lynparza, another Astra drug, was given FDA priority review for a severe form of prostate cancer, the company said separately. The medicine is approved for tumors of the breast and ovaries.
Astra’s stock was little changed in London, trading at 7,869 pence.

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