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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Regulatory collaboration is expected to help speed up drug approvals • Source: Alamy

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.

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