(Reuters) - A panel of European Medicines Agency (EMA) has recommended granting conditional marketing approval to Clovis Oncology’s drug for ovarian cancer, citing anti-tumour activity.
However, the EMA's Committee for Medicinal Products for Human Use (CHMP) listed fatigue, nausea, creatinine elevations and liver enzymes elevations goo.gl/fQ9iJh as most common side effects of the drug, rubraca.
Like Tesaro Inc’s niraparib and AstraZeneca’s lynparza, the drug belongs to a closely watched class of new medicines called PARP inhibitors, which block enzymes involved in repairing damaged DNA, thereby helping to kill cancer cells.
The panel also proposed that the drug should be prescribed by physicians experienced in the use of anti-cancer medicines.
CMPH’s opinions are normally endorsed by the European Commission within a couple of months.
In 2016, the U.S. Food and Drug Administration granted accelerated approval here to the drug in patients with a specific gene mutation whose disease had advanced despite two or more rounds of chemotherapy.
Reporting by Rahul B in Bengaluru; Editing by Anil D'Silva