REUTERS/Suzanne Plunkett
A tray containing cancer cells sits on an optical microscope in the Nanomedicine Lab at UCL's School of Pharmacy in London.
The drug, called Rubraca, is approved to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation. That gene mutation, deletrious BRCA, will have to be identified via a genetic test that the FDA approved Monday.
Clovis Oncology, the drugmaker behind Rubraca, was up 15% on the news of the approval.
Rubraca is part of a class of cancer drugs called PARP inhibitors, which blocks a particular enzyme that's used by our cells to repair DNA so that tumors can't survive. In certain kinds of cancer that repair system is broken allowing cancer cells to thrive, so blocking it is critical.
The drugs seem to work particularly well in people with the BRCA gene mutations, which disable other DNA repair mechanisms.
Clovis isn't the only drugmaker going after PARP inhibitors: a number of other companies are developing their own versions, including Pfizer, which sold its original PARP inhibitor to Clovis back in 2011.
(Reuters reporting by Divya Grover in Bengaluru; Editing by Martina D'Couto)