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New Cancer Drug Gets Green Light

Image: New Cancer Drug Gets Green Light
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Thursday, 22 Oct 2015 12:45 PM

Merrimack Pharmaceutical Inc.'s pancreatic cancer therapy, Onivyde, became its first ever drug to win approval from the U.S. Food and Drug Administration on Thursday.

The drug when used in combination with chemotherapy drugs 5-fluorouracil (5-FU) and leucovorin, is designed to treat metastatic pancreatic cancer in patients who have failed to respond to chemotherapy drug gemcitabine.

The drug is not approved for use as a single agent for the treatment, the agency said on Thursday.

However, the drug carries a black box warning, FDA's most severe and restrictive warning, about possible risks of diarrhea and neutropenia - an abnormally low count of white blood cells in the body, the agency noted.

Pancreatic cancer, which is known as the "deadliest" kind of cancer, is seldom detected in its early stages.

The disorder accounts for only 3 percent of all cancers and 7 percent of cancer deaths in the United States, according to the American Cancer Society.

Merrimack shares were halted prior to the announcement. The company's shares closed at $10.01 on the Nasdaq on Wednesday.

© 2017 Thomson/Reuters. All rights reserved.

   
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Merrimack Pharmaceutical's pancreatic cancer therapy, Onivyde, became its first ever drug to win approval from the U.S. Food and Drug Administration on Thursday.
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2015-45-22
Thursday, 22 Oct 2015 12:45 PM
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