Robert Hadley | Apr 6, 2017

FDA clears ovarian cancer drug for broad uses

Zejula, an anti-cancer drug that inhibits the ability of tumor cells to self-repair, has been approved by the Food and Drug Administration (FDA) for sale in the United States after a clinical trial showed the drug works on a broader range of cancers.

In its March 29 announcement, Zejula manufacturer Tesaro Inc. showed positive results during a clinical trial on more than 550 women suffering from ovarian, fallopian tube or peritoneal cancers. The study showed the once-a-day pill was equally effective on cancers resulting from a genetic mutation, as well as those caused by other factors.

Although Tesaro’s PARP-inhibiting drug is one of three medications that cut enzymes responsible for tumor repair, Zejula was found effective on cases that return after going into remission.

The FDA used accelerated review processes and financial incentives to bring Zeluja quickly to market, the release stated.

The side effects of the new treatment may include high blood pressure, a possible risk of myeloid leukemia and a reduction in bone-marrow blood cell count.

Organizations in this story