In January 2021 the UK will join Project Orbis, the US-led collaborative scheme that enables international regulators to simultaneously review and approve new cancer drugs faster.
The UK medicines agency, the MHRA, will join the scheme fully on 1 January, after the end of the Brexit transition period, health secretary Matt Hancock said this week.
Project Orbis was launched in September 2019 and has so far involved collaborations between the drug regulators from the US, Canada, Australia, Singapore and Switzerland.
By joining the scheme, the MHRA will be able to “co-operate with the best medical regulators in the world and make approvals quicker so that we can get patients the fastest possible access to new drugs,” Hancock said on 5 October.
The move was also welcomed by the UK BioIndustry Association. “Since nearly all innovative oncology products are launched in the USA, this new regulatory path may become a key route by which the UK remains an early and priority market for global launches, after the end of the transition period,” said BIA chief executive Steve Bates.
Zepzelca & Tukysa
Project Orbis provides a framework for concurrent submission and review of oncology products among the international regulators.
Collaborative reviews are designed to identify any regulatory divergences across the review teams. As previously noted by the Australian regulator, the TGA, the scheme has introduced efficiencies and established frameworks for process alignment and management of evaluation issues in real time across jurisdictions.
Each regulatory agency then maintains its regulatory process to make an independent decision on market authorization.
In September 2019, the first collaboration under the scheme resulted in the simultaneous approval in the US, Canada and Australia of the use of the previously authorized drugs, Eisai’s Lenvima (lenvatinib) and Merck’s Keytruda (pembrolizumab), in combination to treat certain patients with advanced endometrial carcinoma.
In April, the US Food and Drug Administration approved the first new molecular entity to be reviewed under the scheme – Seattle Genetics’ breast cancer drug Tukysa (tucatinib). The other regulators involved in the review were from Australia, Canada, Singapore and Switzerland. (Also see "US FDA’s Oncology Center In The Lockdown: ‘Business As Usual’" - Pink Sheet, 18 Jun, 2020.)
More recently, in June the FDA granted accelerated approval to PharmaMar’s Zepzelca (lurbinectedin) for metastatic small cell lung cancer, after collaborating with the TGA. (Also see "Keeping Track: US FDA Approvals Include Novel Agents Zepzelca And Uplizna, Biosimilar Nyvepria, Follow-On Semglee" - Pink Sheet, 15 Jun, 2020.)
As well as joining Project Orbis, the MHRA is implementing myriad regulatory changes that will kick in on 1 January when the UK leaves the EU single market and customs union. (Also see "How To Get A ‘Great Britain’ Drug Approval In 2021" - Pink Sheet, 2 Sep, 2020.)