U.S. Fda Grants LYNPARZA® (olaparib) Orphan Drug Designation for Pancreatic Cancer

The United States Food and Drug Administration has granted the drug Lynparza® (olaparib) Orphan Drug Designation for the treatment of pancreatic cancer. Lynparza is used in the US to treat certain forms of breast and ovarian cancer and is now being researched for its potential use in certain patients with pancreatic cancer. For more detailed information, you can view the source press release here, on Merck’s website.

About Pancreatic Cancer

The pancreas is a digestive organ that’s involved in helping to break down food and produce hormones. In people with pancreatic cancer, cells in the pancreas have grown out of control and form a tumour. According to Merck’s article, pancreatic cancer accounts for around 3% of cancers diagnosed in the US. However, often the symptoms of this type of cancer appear at a late stage, and so people may only be diagnosed after the cancer has already progressed.

About Lynparza® (olaparib)

Lynparza is being investigated as a potential therapy for patients with germline BRCA-mutated metastatic pancreatic cancer, whose disease hasn’t progressed after first-line platinum-based chemotherapy. The drug is a PARP inhibitor that may be able to used BRCA mutations (and other DDR pathway deficiencies) to kill cancer cells.

Research into Lynparza

To explore Lynparza’s use as a potential pancreatic cancer therapy, an on-going Phase 3 study is being carried out. It is comparing the effects of Lynraza as a maintenance monotherapy to those of a placebo. 145 patients with germline BRCA-mutated metastatic pancreatic cancer (and whose disease hasn’t progressed after first-line platinum-based chemotherapy) are taking part, and the study will measure progression-free survival.

Orphan Drug Designation

The FDA has recently awarded Lynparza Orphan Drug status for the treatment of pancreatic cancer. This status, which is reserved for drugs intended to treat conditions that affect less than 200,000 people in the US, is designed to support the development of new and needed drugs by offering the developers incentives, such as a longer period of marketing exclusivity. You can read more about Orphan Drug Designation here.

Anna Hewitt

Anna Hewitt

Anna is from England and recently finished her undergraduate degree. She has an interest in medicine and enjoys writing. In her spare time she likes to cook, hike, and hang out with cats.

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