Yahoo Finance AstraZeneca's (AZN) Lynparza Gets Another Orphan Drug Status
AstraZeneca plc AZN and partner Merck & Co., Inc. MRK announced that the FDA granted Orphan Drug designation (ODD) to Lynparza for the treatment of pancreatic cancer.
Notably, the ODD is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States.
We remind investors that in January, Lynparza became the first PARP-inhibitor to be approved for a breast cancer indication in the United States. Lynparza is also approved 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. Lynparza also enjoys ODD status for ovarian cancer as well.
Coming back to the release, the use of Lynparza in pancreatic cancer is being evaluated in the ongoing phase III POLO study, which is testing Lynparza as maintenance monotherapy versus placebo in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following 1st-line platinum-based chemotherapy.
Results from the POLO study are expected in the first half of 2019. Pancreatic cancer is a rare, life-threatening disease that accounts for about 3% of all cancers in the United States and has a huge unmet medical need.
In the second quarter of 2018, Lynparza sales rose 26.1% sequentially to $150 million. Sales in the United States surged 25.8% quarter-over-quarter to $83 million. In Europe, sales rose 7.1% from previous quarter, pushed by a number of successful launches, high BRCA-testing rates and increased penetration.
In 2018, Lynparza received approval in Japan for both ovarian cancer and breast cancer, and in the United States for second indication in breast cancer. These approvals should continue to drive sales further in 2018.
However, pancreatic cancer space is competitive. Another Pharma giant, Eli Lilly and Company LLY, added a pancreatic cancer candidate, pegilodecakin, to its portfolio after it acquired California-based immuno-oncology biotech, ARMO Biosciences in June 2018. Another company, Celgene Corp. CELG is working to expand the label for its drug, Abraxane for the treatment of pancreatic cancer, among others.
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