AstraZeneca (AZN - Free Report) announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending the approval of its PARP inhibitor, Lynparza (olaparib) for two label expansions in Europe.
The first recommendation is for Lynparza as a first-line maintenance treatment for HRD-positive advanced ovarian cancer in combination with Roche’s (RHHBY - Free Report) Avastin (bevacizumab). The CHMP also recommended approving the drug for metastatic castration-resistant prostate cancer (mCRPC) with germline and/or somatic BRCA mutations in patients whose disease has progressed following prior treatment with new hormonal agent treatments like J&J’s (JNJ - Free Report) Zytiga and Pfizer (PFE - Free Report) /Astellas’ Xtandi. The drug is approved for both indications in the United States.
Please note that Lynparza is already approved as monotherapy for first-line maintenance treatment of BRCA-mutated ovarian cancer. The drug is also approved for treating germline BRCA-mutated metastatic pancreatic cancer and metastatic breast cancer.
The CHMP opinion for ovarian cancer indication is based on data from the phase III PAOLA-1 study, which demonstrated that Lynparza in combination with Avastin reduced the risk of disease progression or death by 67% compared to Avastin alone.
The positive CHMP nod for prostate cancer indication was based on data from the phase III PROfound study. Data showed that treatment with Lynparza led to a significant and clinically meaningful improvement in overall survival and median radiographic progression-free survival in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations, versus Zytiga and Xtandi.
We note that AstraZeneca is also developing Lynparza as first-line treatment for mCRPC in combination with Zytiga in a phase III study. Data from the study is anticipated next year.
Shares of AstraZeneca have gained 12.1% so far this year compared with the industry’s increase of 1.8%.
Lynparza is the leading PARP inhibitor as it is approved for treating four different types of cancer. The drug generated sales of $816 million in the first half of 2020, reflecting growth of 60% year over year, at constant exchange rate. The approval of the drug as first-line maintenance treatment in combination with Avastin and for treating mCRPC patients in the United States in May and potential approval in Europe for these indications is likely to boost its sales further. Moreover, label expansion of the drug also helps it to maintain its leadership compared to two other approved PARP inhibitors — Glaxo’s Zejula and Clovis Oncology’s Rubraca.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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