GENE ONLINE|News &
Opinion
Blog

2020-03-25| Asia-PacificLicensing

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

by GeneOnline
Share To

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.

Related Article: Gilead’s Antiviral Drug, Epclusa gets FDA Nod for Pediatric Hepatitis C

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

 

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
Wegovy Expands Its Reach: First Weight-Loss Medication Approved to Reduce Cardiovascular Risk
2024-03-11
Groundbreaking CRISPR/Cas9-based Genome Editing Therapy Secured the Second FDA Approval
2024-01-18
Neurolief’s Neuromodulation Device Receives Japanese Approval for At-Home Migraine Treatment
2024-01-16
LATEST
Innovative Cellular Mapping of BRCA-Related Breast Cancer Findings Reveals Novel Therapeutic Targets
2024-03-29
Previewing AACR 2024 With Select Pre-Meeting Highlights
2024-03-28
Roche Delivering on Malaria Screening Solutions for Blood Donation
2024-03-28
Innovating Cancer Treatment: The Role of ADC Technology at Nona Biosciences
2024-03-28
BIO CHINA 2024 Brings Biotech Experts and Industry Elites Together for Innovation
2024-03-27
Galderma’s Strong European IPO Debut
2024-03-26
Markets and Mergers: Boston Scientific and Axonics Shake Hands on Deal
2024-03-25
EVENT
2024-04-06
Biotech Innovation Funding Networking
Los Angeles, USA
Scroll to Top