AstraZeneca first-in-class ovarian cancer drug wins EU approval

In In The News by Barbara Jacoby

Reporting by Ben Hirschler; editing by Jason Neely


AstraZeneca’s all-important cancer drug business received a fillip on Thursday as a new medicine against ovarian cancer was approved in Europe, making it the first of its kind to reach the market.

AstraZeneca has flagged Lynparza, or olaparib, as a potential $2-billion-a-year seller.

The formal approval from the European Commission had been expected after the European Medicines Agency gave the drug a green light in October but the news is still significant given earlier uncertainties.

In the United States, the drug hit a road bump in June when a panel voted against its accelerated approval. The British company now expects to hear back from U.S. regulators on its approvability in the world’s biggest market by Jan. 3.

Lynparza blocks an enzyme involved in cell repair and is designed for ovarian cancer patients with certain hereditary gene mutations. It also has promise in treating other cancers, including breast and gastric tumors, opening up a substantial market opportunity.

The treatment is the first in the so-called oral poly ADP-ribose polymerase (PARP) inhibitor class to reach the market.

Cancer medicine is central to AstraZeneca’s claims that it has a strong independent future, after fending off a $118 billion takeover bid from Pfizer in May.