Japan Grants Orphan Drug Designation to Lynparza for Germline BRCA-mutated Pancreatic Cancer

Last week, AstraZeneca announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted its PARP inhibitor Lynparza (olaparib), an orphan drug designation for the maintenance treatment of germline BRCA-mutated (gBRCAm) curatively unresectable pancreatic cancer. Lynparza is co-developed and co-commercialized with MSD Inc (MSD: known as Merck & Co., Inc. inside the US and Canada).

Among the most common forms of cancers, pancreatic cancer has the lowest survival rate and is the only major cancer that has a five-year survival rate of less than 10% in almost every country. “Japan has the fifth-highest incidence of pancreatic cancer worldwide and patients have seen limited treatment advances over the last few decades. This designation is an important step forward in bringing the first targeted medicine to biomarker-selected patients with advanced pancreatic cancer in Japan,” commented José Baselga, Executive Vice President, R&D Oncology, AstraZeneca.

Following a successful Phase III POLO trial, Lynparza was approved in the United States as a first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer last December, with ongoing regulatory reviews in the European Union and other jurisdictions. Lynparza showed a statistically significant and clinically meaningful improvement in progression-free survival, a primary endpoint of the trial. The drug nearly doubled the time patients lived, without disease progression or death to a median of 7.4 months as compared to 3.8 months on placebo. Besides, it also performed well on other clinically relevant endpoints. The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in previous trials.

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References

1. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/lynparza-granted-orphan-drug-designation-in-japan-for-brca-mutated-metastatic-pancreatic-cancer.html
2. https://www.astrazeneca.com/media-centre/press-releases/2019/lynparza-approved-in-the-us-as-a-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer-30122019.html
3. https://clinicaltrials.gov/ct2/show/NCT02184195
4. https://www.nejm.org/doi/full/10.1056/NEJMoa1903387

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