Aslan Pharmaceuticals announced that commercialisation of varlitinib in China, if approved, is expected to begin approximately one year earlier than previously anticipated
Aslan Pharmaceuticals is a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the US and Europe.
The shortened timeline to commercialisation for varlitinib follows recent discussions with the Chinese Food and Drug Administration (CFDA) regarding its planned clinical development strategy for varlitinib in biliary tract cancer.
Aslan initiated a pivotal, single-arm, multicentre clinical trial of varlitinib plus capecitabine in China, for patients with advanced or metastatic biliary tract cancer who have progressed on at least one line of prior chemotherapy in 2017.
Professor Shukui Qin, Chair of the Chinese Society of Clinical Oncology and Deputy Director of the Nanjing 81 Hospital, is the lead investigator for the trial.
The trial will assess the safety and efficacy of varlitinib in combination with capecitabine in a total of 68 patients and is now actively enrolling patients.
The primary endpoint will be objective response rate. Aslan expects to report top-line data from this trial in late 2018 and if the primary endpoint is met, subsequently submit its first regulatory filing for approval for second-line biliary tract cancer to the CFDA, ahead of previous timelines that anticipated longer clinical development.
Dr Carl Firth, CEO of Aslan Pharmaceuticals, said: “Recent regulatory changes mean that the development of innovative drugs addressing areas of high unmet need in China, such as biliary tract cancer, can potentially be accelerated.”
“This may allow us to bring important new therapies to patients with few treatment options sooner. Following our recent agreement to acquire the full global rights to develop and commercialise varlitinib, we are now starting to build our organisation in China to prepare for the anticipated launch of varlitinib.”
Aslan is working closely with its manufacturing partner in China and in 2017 established the manufacturing process of varlitinib to cGMP standards. A commercial supply chain is expected to be validated in China in 2018 and 2019 to support a potential regulatory filing and if approved, subsequent commercial supply.
Annually, there are approximately 200,000 new cases of biliary tract cancer in Asia, of which up to 145,000 are in China and approximately 12,600 new cases in the US, where biliary tract cancer is considered to be an orphan disease. There are currently no approved treatments in China or the US.