AstraZeneca snags EU approval for first-in-class cancer fighter Lynparza

AstraZeneca's headquarters in London--Courtesy of AstraZeneca

AstraZeneca ($AZN) scored European approval for its ovarian cancer-treating drug Lynparza (olaparib), expanding its cancer portfolio at a time when the company is trying to show investors that it's better off independent.

The European Commission based its approval on Phase II trial data, which compared Lynparza with a placebo in relapsed patients with serious ovarian cancer. The study showed that the drug significantly prolonged survival rates in individuals with BRCA-mutated ovarian cancer--an average of 11 months as opposed to four months in the control group. Clinical trials also showed that Lynparza has relatively mild side effects compared with traditional cancer-fighting drugs, AstraZeneca said in a statement.

AstraZeneca's drug is a poly ADP-ribose polymerase (PARP) inhibitor, the first in that new class of treatments. PARP inhibitors are designed to zero in on cancer cells and leave a patient's normal cells undamaged. Besides ovarian cancer, AstraZeneca is testing Lynparza against a variety of other cancers.

"We are delighted to be able to bring this much needed treatment to patients with BRCA-mutated ovarian cancer whose options are currently very limited," Briggs Morrison, AstraZeneca's chief medical officer, said in a statement. "[T]oday's news marks only the first of what we hope will be a number of indications in which Lynparza has the potential to transform the lives of cancer patients including those with breast, pancreatic and gastric cancers."

European approval for Lynparza bodes well for AstraZeneca, as it continues to beef up an oncology pipeline it appraises at $12 billion. And as the first to market, Lynparza has an edge on competition from AbbVie ($ABBV) and Clovis Oncology ($CLVS), which are forging ahead with their own BRCA therapies. The U.K. drugmaker maintains that Lynparza can eventually rack up $2 billion a year in sales, a figure it cited when fending off Pfizer's ($PFE) unwelcome pursuit in May.

But AstraZeneca faces some regulatory hurdles in the U.S., as the FDA already gave the drug a thumbs-down in a early review. Over the summer, an FDA panel of experts voted 11-2 against recommending an early approval for Lynparza, pointing to the drug's failure to significantly improve overall survival, citing some worrisome adverse events and questioning its study data. The company expects to hear back about FDA approval for Lynparza in January.

- read AstraZeneca's statement
- here's the London Evening Standard's take
- read more about Lynparza here

Special Report: The top 10 pharma companies by 2013 revenue - AstraZeneca

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