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AstraZeneca's Two New Cancer Drugs Get Approval in Japan

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AstraZeneca (AZN - Free Report) announced that the Japanese regulatory authorities have granted approval to its PARP inhibitor, Lynparza tablets for the treatment of patients with unresectable or recurrent BRCA-mutated metastatic breast cancer in patients who have received prior chemotherapy. With this approval, Lynparza becomes the first and only PARP inhibitor approved for use beyond ovarian cancer in Japan. This is the second indication for which Lynparza is now approved in Japan. Lynparza was approved for the first indication — advanced ovarian cancer regardless of BRCA mutation status — in the country earlier this year.

AstraZeneca’s shares have risen 0.3% so far this year. In contrast, the industry has declined 5.1%.

In United States, Lynparza was approved for a breast cancer indication this January.

Lynparza is also presently marketed for advanced ovarian cancer in later settings.

Lynparza is also in different studies for a range of tumor types including breast, prostate and pancreatic cancers as well as earlier-line settings for ovarian cancer.

In the first quarter of 2018, Lynparza sales rose 100% to $119 million. Sales in the United States surged 144%, gaining from recent label expansion approvals in ovarian cancer, tablets, and breast cancer indication. In Europe, sales rose 44%, pushed higher by a number of successful launches, high BRCA-testing rates and encouraging levels of reimbursement.

AstraZeneca has a joint development and collaboration agreement with Merck (MRK - Free Report) for Lynparza.

AstraZeneca’s another cancer drug Imfinzi was also approved in Japan for an early-stage lung cancer indication. The PD-L1 inhibitor was approved for patients with locally-advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT).The approval was based on positive progression free survival data from the phase III PACIFIC study.

Imfinzi is already approved in the United States, Canada, Switzerland and India in this indication while an application in the EU is under review, with a decision expected in the second half.

Meanwhile, Imfinzi (durvalumab) is being evaluated for multiple cancers, either alone or in combination with other regimens, including late-stage studies in combination with tremelimumab in hepatocellular carcinoma (HCC, liver cancer), NSCLC, small cell lung cancer, metastatic urothelial cancer and head and neck squamous cell carcinoma (HNSCC) among others.

Imfinzi was launched in the United States for the first indication — second-line advanced bladder cancer — in May last year. Thereafter, Imfinzi was approved and immediately launched for early-stage lung cancer in the United States in February this year, which contributed significantly to the drug’s $62 million sales in the first quarter of 2018.

AstraZeneca has a Zacks Rank #4 (Sell).

Better-ranked large-cap pharma stocks include Pfizer, Inc. (PFE - Free Report) and AbbVie, Inc. (ABBV - Free Report) both with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Pfizer’s stock has gained 7.4% in the past year. Earnings estimates for 2018 as well as 2019 rose 0.3% in the last 60 days.

AbbVie’s stock has rallied 28.5% in the past year. Earnings estimates for 2018 increased 0.3% while that for 2019 rose 0.2% in the last 60 days.

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