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AstraZeneca's (AZN) Lynparza Approved in Japan for 3 Cancers

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AstraZeneca Plc. (AZN - Free Report) and Merck (MRK - Free Report) announced that their PARP inhibitor, Lynparza (olaparib), was approved by the Japanese Ministry of Health, Labour, and Welfare for the treatment of advanced ovarian, prostate and pancreatic cancers.

Shares of AstraZeneca have increased 1.8% this year so far compared with the industry’s growth of 5.4%.

The first approval as a first-line maintenance treatment in combination with Roche’s (RHHBY - Free Report) Avastin (bevacizumab)for patients with HRD-positive advanced ovarian cancer was based on data from the PAOLA-1 phase III study. In the PAOLA-1 study, HRD-positive ovarian cancer patients had longer median progression-free survival on Lynparza plus Avastin maintenance treatment compared to those on Avastin alone.

The second approval was for the treatment of BRCA gene-mutated (BRCAm) castrate-resistant prostate cancer (mCRPC),which was based on a subgroup analysis of the PROfound phase III study. The study showed that men with BRCA1/2-mutated metastatic castrate-resistant prostate cancer on Lynparza had longer radiographic progression-free survival (PFS) and overall survival than those on Pfizer’s (PFE - Free Report) Xtandi (enzalutamide) or J&J’s Zytiga (abiraterone).

The third approval was for BRCAm metastatic pancreatic cancer based on the results of the POLO phase III study,wherein Lynparza demonstrated a statistically significant and clinically meaningful improvement in PFS versus placebo in patients with germline BRCAm metastatic pancreatic cancer.

Lynparza is presently approved to treat four types of cancers — ovarian, breast, pancreatic and prostate — in certain patient populations in the United States. It is also approved for all or some of these cancers in several other countries.Lynparza is also being evaluated in the earlier-line setting for the approved cancer indications.

The drug generated sales of $1415 million in the first nine months of 2020, reflecting growth of 28% year over year. The drug contributes to growth of the company’s oncology division.

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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