TESARO Inc (NASDAQ:TSRO), which happens to be one of the Top Biotech Stocks has expressed its excitement after FDA made the move to approve its ovarian cancer drug. This is not only a moment of excitement for the high end company, but also a moment of excitement and hope for persons struggling with cancer around the globe. According to a number of the market analysts, Tesaro may just be on the way to surpassing $2 billion in peak sales.
The Tesaro shares shot up by 6 percent in after-hours trading as of 8 p.m after the provider made the announcement that indeed Niraparib had been approved. Niraparib is a once-daily and according to the provider, Zejula will be the brand name it will be sold under.
The 430-employee provider confidently asserted that regulators by mid-2017 will have issued its decision. Asides from being early, the broad was termed as quite broad. It deals with treating patients struggling with recurrent fallopian tube, ovarian, and primary peritoneal cancer who have showcased a response to chemotherapy-either partially or completely.
Most importantly, the label does not in anyway bar the drug for use in patients who have already tested positive for a given gene mutation by the name which is usually associated with women struggling from ovarian cancer.
Zejula falls in a category of drugs called PARP inhibitors which usually work through a mechanism of blocking those enzymes which cancer cells utilize to repair themselves after the chemotherapy sessions or any other kinds of stress.
The FDA has already done its part by approving PARP inhibitors manufactures by some two other companies. However, the given approvals were limited to persons exhibiting BRCA mutation.
Zejula was approved based on a 553-patient Phase 3 trial. According to some data released in the month of October, it came to light that the drug had assisted patients who had gone through chemotherapy to survive longer as well as tone down the growth of their tumors.
In line with Monday’s announcement, the company, which happens to be one of the Best Biotech Stocks, declared its plan to expand Zejula’s development while at the same time putting it under examination as a potential form of treatment for breast, lung and metastatic ovarian cancer.