Kids & Family

New Cancer Treatment Receives 'Breakthrough' Designation From FDA

A new treatment for one of the deadliest forms cancers has received a "breakthrough" designation from the Food and Drug Administration which means approval could come in months rather than years.

Aduro BioTech, Inc. received the designation after positive clinical evidence in the treatment of pancreatic cancer. A breakthrough designation is reserved for drugs that would treat a serious or life threatening condition and preliminary clinical evidence shows great potential for improvement over available therapies, the FDA states.

The San Francisco Business Times reported that Audro's cancer immunotherapy combines two previous cancer therapies that had been abandoned by previous researchers. The times reported that the FDA's action could result in drugs being approved in as soon as 60-days, but it does not guarantee approval of the therapy.

The National Cancer Institute reports that pancreatic cancer remains among the most deadly. In 2014, the instituted estimated 46,420 news cases of with 39,590 deaths.

Audro enrolled 93 metastatic pancreatic cancer patients in its first trial and the median survival of the patients increased from 3.9 months to 6.1 months.

“We are extremely pleased to receive Breakthrough Therapy Designation and the high degree of FDA collaboration toward advancement of our program that it confers,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro.

“This designation underscores the potential of our combination immunotherapy approach to make a difference in the lives of patients with pancreatic cancer, which remains a very difficult cancer to treat,” he said.


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