FDA to review expansion of Clovis’ drug
BOULDER — Clovis Oncology Inc. (Nasdaq: CLVS) is having its marketing application reviewed by the Food and Drug Administration to use its drug for maintenance treatment for cancer patients.
Specifically, the review will look at approving the use of Rubraca as maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and who are platinum-sensitive.
The FDA is expected to reveal whether it approves or denies the application on April 6.
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The FDA approved Rubraca for use in certain patients with ovarian cancer in December 2016. In October, Clovis submitted the marketing application for expanded use of Rubraca.
BOULDER — Clovis Oncology Inc. (Nasdaq: CLVS) is having its marketing application reviewed by the Food and Drug Administration to use its drug for maintenance treatment for cancer patients.
Specifically, the review will look at approving the use of Rubraca as maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and who are platinum-sensitive.
The FDA is expected to reveal whether it approves or denies the application on April 6.
The FDA approved Rubraca for use in certain patients with ovarian cancer in December 2016. In October,…
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