Swissmedic approves first new active substance as part of Project Orbis

Tucatinib for the treatment of a particularly aggressive type of breast cancer reviewed in four months


Swissmedic approved TUKYSA film-coated tablets (active substance: tucatinib) for the treatment of patients with HER2-positive metastatic breast cancer in Switzerland on 7 May 2020. The Agency assessed the authorisation application for the new active substance (NAS) concurrently with the US FDA and the other members of the ACSS consortium (Australia’s TGA, Health Canada and the Singaporean HSA). Concurrent transnational review by different regulatory authorities offers a way of delivering faster patient access to innovative cancer treatments.

While participating in the review, which was conducted as part of Project Orbis – an initiative of the FDA Oncology Center of Excellence – Swissmedic combined phases I and II, sending rolling questions to the applicant. As a result, it was possible to meet the short process deadline of 123 days in total.

In a next step, Swissmedic intends to extend the Project Orbis pilot phase and take part in the concurrent review of further applications. These will primarily involve simultaneously submitted applications for indication extensions and first-time authorisations of new active substances.

Once the pilot phase is completed within a year, Swissmedic will decide whether to continue with Project Orbis in the long term.

Concurrent review of innovative cancer medicines under Project Orbis

The project provides a framework for the concurrent submission and review of oncology products among leading international regulatory agencies. The authorisation application for tucatinib was submitted to the US Food and Drug Administration (FDA) on 20 December 2019. Swissmedic received the application shortly afterwards, on 6 January 2020. The FDA approved tucatinib on 17 April 2020, while Swissmedic authorised it for Switzerland on 7 May 2020.

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