December 22, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
News that the U.S. Food and Drug Administration has approved accelerate approval for AstraZeneca ’s ovarian cancer drug Lynparza has many analysts to conjecturing that the drug will soon be taking full advantage of what the company predicts will be a $2 billion a year market.
AstraZeneca announced accelerated FDA approval for Lynparza on Friday, a day after European Union regulators green lit the drug for use in its jurisdictional nations. The FDA decision was a surprising twist, because in June the regulator’s own advisory panel had voted against granting an accelerated approval to the drug, citing inadequate data.
But because Lynparza is designed to treat ovarian cancer in patients with certain hereditary gene mutations, and might have applications for treating other cancers such as breast and gastric tumors, it’s possible the FDA is giving AstraZeneca a chance to allow the drug to prove itself in the wider market.
“Lynparza is an excellent example of how advances in the understanding of cancer biology can be used to develop the next generation of targeted medicines,” said Briggs Morrison, executive vice president of global medicines development and chief medical officer at AstraZeneca, in a statement. “It is a much-needed new therapeutic option for patients with germline BRCA-mutated advanced ovarian cancer. Today’s approval also marks the first of what we hope will be a number of indications in which this medicine has the potential to improve the lives of cancer patients.”
Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumor DNA repair pathway deficiencies to target and kill cancer cells. It is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, as detected by an FDA approved companion diagnostic test, BRACAnalysis CDx.
“Despite the fact that shares of AstraZeneca have largely declined ever since the announcement of new tax inversion laws, coupled with Pfizer ‘s announcement of a massive stock buyback--both of which essentially solidified that it will not attempt to acquire AZN--I reiterate my bull thesis on AZN, following the FDA approval for olaparib,” said biotech columnist Trevor Lowenthal on Seeking Alpha Monday.
“With approvals in the U.S. and the EU, AZN now has the opportunity to penetrate a large market in ovarian cancer, currently estimated at $19 billion, and projected to rise to $35 billion by 2018,” said Lowenthal. “Furthermore, CEO Pascal [Soriot] is very optimistic about the market potential for olaparib, having routinely stated that it could be a $2 billion-a-year seller. Ultimately, I’m inclined to agree, for not only is olaparib the first PARP inhibitor in its class to reach the EU, but it is also indicated for a variety of different cancers, which should increase AZN‘s market opportunity.”
