Japan backs AstraZeneca pancreatic cancer drug
Cambridge headquartered Big Biotech AstraZeneca has clinched a major coup in Japan for its projected blockbuster cancer drug Lynparza (olaparib).
The company has been granted orphan drug designation (ODD) in Japan for the maintenance treatment of germline BRCA-mutated (gBRCAm) curatively unresectable pancreatic cancer.
Lynparza is co-developed and co-commercialised with MSD Inc (Merck & Co) based in New Jersey.
The Japanese Ministry of Health, Labour and Welfare grants ODD to medicines intended for the treatment of diseases that affect fewer than 50,000 patients in Japan and for which there is a high unmet medical need.
Pancreatic cancer has the lowest survival rate of the most common cancers and is the only major cancer with a five-year survival rate below 10 per cent in almost every country. It is the fourth leading cause of cancer death in Japan, resulting in 37,000 deaths in 2018.
José Baselga, executive VP for R & D Oncology, said: “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.”
Roy Baynes for MSD Research Laboratories, added: “A pancreatic cancer diagnosis is devastating and we are committed to research that aims to change the prognosis for patients.
“The previously reported POLO trial demonstrated that treatment with Lynparza extended time without disease progression or death in patients with germline BRCA-mutated metastatic pancreatic cancer and we are hopeful that we will be able to bring this treatment to patients in Japan soon.”
The Phase III POLO trial showed Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo.
The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in previous trials.
Lynparza was approved in the US as a first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer in December with ongoing regulatory reviews in the EU and other jurisdictions.