FDA Amends Original Approval of Ovarian Cancer Drug Zejula, Expanding Availability

According to a publication from OncLive, the Food and Drug Administration (FDA) recently granted priority review status to a supplemental biologics license application for Zejula. Zejula (generic name niraparib) is a small molecule drug that was first approved by the FDA in 2017 for the “maintenance treatment” of certain cases of advanced fallopian, ovarian, or peritoneal cancer.

About Ovarian, Fallopian Tube, and Peritoneal Cancer

Ovarian cancer is, despite its name, somewhat of an umbrella term. Cancers that originate in the ovaries, fallopian tubes, and peritoneum are all closely related. The term “ovarian cancer” can broadly refer to any of these cancers — the areas affected are so close together it can be difficult to determine where a particular cancer originated.

Every year, there are over twenty-two-and-a-half thousand new ovarian cancer diagnoses. Most of these cancers will be high-grade serous carcinomas — which have the lowest survival rates of all ovarian cancers. Although ovarian cancers only account for 2.5% of cancers cases affecting women, they’re also responsible for 5% of all cancer deaths.

Treatment is more effective in the cancer’s early stages. However, 59% of women with ovarian cancer aren’t diagnosed before the disease has progressed to an advanced stage. That’s because for a long time, physicians had no techniques available to detect the cancer’s presence early. Recent technological advances have made early detection possible to an extent, but are still unable to definitively provide a diagnosis in many cases.

Zejula Receives Modified Biologics License Application Approval

Zejula was first approved by the FDA in 2017 for the “maintenance treatment” of advanced ovarian cancers that had responded well to platinum-based chemotherapy.

Just this June, the FDA approved Massachusetts-based Tesaro’s modified biologics license application for the drug. The new ruling “adjusts” Zejula’s existing approval status to apply to the treatment of people with advanced ovarian cancers who have already undergone more than two regimens of chemotherapy, have a mutation on the BRCA gene or have homologous recombination deficiency, and who have shown positive response to platinum-based chemo.

Essentially, Zejula will now be available to slightly more ovarian cancer patients than it was before. However, that’s commendable — a slight increase in the availability of a treatment can save lives when dealing with a condition like ovarian cancer.


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