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- 03/29/2017

FDA gives an early approval to a new drug to treat ovarian cancer developed by Tesaro

Pharma Horizon

Tesaro Inc., the Waltham biotech, developed  an innovative new drug to treat ovarian cancer that receive an unsual early approval from FDA. The regulators have issued their decision unusually three months early instead of late June as initially planned, undelining the urgent need to find new ways to treat ovarian cancer, a disease for which there are few medical options. Ovarian cancer is  the fifth most frequent cause of cancer death in women, and the cancer recurs in 85 percent of patients within two years of chemotherapy.

Zejula approval, this the brand name under which the drug will be launched in the United States late April, is  a once-a-day pill and is a PARP inhibitors, that work by preventing cancer cells from replenishing their DNA.
Analysts have projected that this new drug  could quickly become a blockbuster treatment that could generate  sales up to $1 billion a year. 

The new drug has been approved by the FDA to treat women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer after they’ve had chemotherapy.

Tesaro president Mary Lynne Hedley said in an interview  that the company plans to test the drug compound in other cancer patients starting later this year. If successful, more drug approvals could follow in the next three to four years.


Source: The Boston Globe



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