(Alliance News) - AstraZeneca PLC on Tuesday said the US Food & Drug Administration granted its supplemental new cancer treatment drug Lynparza a priority review.
Lynparza will be reviewed for the treatment of patients with BRCA-mutated or HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
In trials, Lynparza has demonstrated a significant and clinically meaningful improvement in invasive disease-free survival and reduced the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo, AstraZeneca said.
The drug was jointly developed and commercialised by Cambridge, England-based AstraZeneca and Merck Sharp & Dohme Corp, a subsidiary of Kenilworth, New Jersey-based pharmaceutical company of Merck & Co Inc.
Lynparza has been used to treat over 40,000 patients worldwide.
It is approved in the US, the EU, Japan, China, and several other countries as first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following the response to platinum-based chemotherapy.
In the EU, the drug is also approved for treatment with patients, who have locally advanced breast cancer.
According to the pharmaceutical firm, there are further regulatory reviews underway in several countries for ovarian, breast, pancreatic and prostate cancers.
Shares in AstraZeneca were down 1.8% at 8,216.00 pence each on Tuesday morning in London.
Merck closed down 5.4% at USD74.89 in New York on Monday, trading down a further 1.1% in pre-market trade on Tuesday.
By Abby Amoakuh; abbyamoakuh@alliancenews.com
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