Specialised Therapeutics (ST) has scored approval for Qinlock in New Zealand, marking the second of five regions that the company has rights to commercialise the advanced gastrointestinal stromal tumour (GIST) treatment.
The Singapore headquartered company was established to commercialise new therapies and technologies to patients in Australia, New Zealand and across South-East Asia.
It secured exclusive distribution rights for Qinlock in five regions – Australia, New Zealand, Singapore, Malaysia, and Brunei – in a deal with US-based Deciphera back in November 2020.
Locally, the oral treatment was approved in July 2020 under Project Orbis and has been available on the PBS for over a year.
Qinlock is currently being made available to eligible patients in New Zealand via a co-pay Access Program while it is considered by PHARMAC for reimbursement.
ST Co-founder and CEO, Carlo Montagner said: “We are hopeful for a positive outcome by PHARMAC so that patients with advanced GIST in New Zealand have ready access to this important new treatment option.”
Qinlock belongs to a class of drugs known as tyrosine kinase inhibitors and is designed to inhibit key enzymes linked to tumour growth.
A pivotal Phase 3 clinical trial in patients with advanced GIST showed that Qinlock was able to reduce the risk of disease progression by 85 per cent with a median progression-free survival of 6.3, compared to one month in the placebo arm.
Last year, the drug was one of 33 nominees for the prestigious Prix Galien USA Awards in the ‘Best Pharmaceutical Agent’ category.
Singapore’s Health Sciences Authority has been evaluating Qinlock since mid-2022, meaning it’s the next likely regulator to make a decision on registration.