Tagrisso (osimertinib), AstraZeneca’s lung cancer treatment, has become the first product to be approved by the UK medicines regulator under Project Orbis, the US-led scheme that enables international regulators to simultaneously review new cancer drugs and approve them faster.
UK Pips EU To The Post With ‘Project Orbis’ Approval For Tagrisso
EU Early-Use Approval For AstraZeneca’s NSCLC Drug Imminent
The UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.

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England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.