FDA Roundup: New Options for Ovarian Cancer, HCV, UTI
Zerbaxa - Infections
The FDA has approved Zerbaxa (ceftolozane/tazobactam) for the treatment of complicated intra-abdominal infections and urinary tract infections.1
Zerbaxa combines and antibacterial drug and a beta-lactamase inhibitor, is the fourth antibacterial drug to be approved this year.
Its efficacy to treat intra-abdominal infections was tested in a trial of 979 adults, and its efficacy at treating urinary tract infections was tested in a trial of 1068. In both trials, Zerbaxa was shown to be effective in the treatment of the infections.
Side effects include nausea, diarrhea, headache, and fever.
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Viekira Pak – Hepatitis C
The FDA has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) for the treatment of patients with chronic hepatitis C and those with advanced liver cirrhosis.2
The 3 drugs within Viekira Pak work together to inhibit the growth of the hepatitis C virus, and was tested in 6 trial containing a total of 2308 partcipants with chronic hepatitis C and without cirrhosis. The trials showed that 91% to 100% of participants who received Viekira Pak achieved sustained virologic response.
The most common side effects were fatigue, itching, weakness, nausea, and sleep difficulties.
Lynparza – Ovarian Cancer
The FDA has approved Lynparza for the treatment of advanced ovarian cancer associated with defective BRCA genes.3
Lynparza, a poly-ADP-ribose polymerase inhibitor, is intended for women with heavily treated ovarian cancer.
In a trial of 137 participants, 34% experienced objective response rate for an average of 7.9 months while taking Lynparza.
Side effects include nausea, fatigue, vomiting, diarrhea, indigestion, and headache.
—Michael Potts
- FDA. FDA approves new antibacterial drug Zerbaxa [press release]. 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427534.htm.
- FDA. FDA approves Viekira Pak to treat hepatitis C [press release]. 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427530.htm.
- FDA. FDA approves Lynparza to treat advanced ovarian cancer [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427554.htm.