BACKGROUND:

As cancer treatment innovation rapidly evolves, faster access for patients with high unmet needs remains a key priority for all stakeholders. Project Orbis (PO) was launched in 2019 by the US Food and Drug Administration (FDA) Oncology Center of Excellence, in collaboration with several regulatory agencies from key markets, with the aim to accelerate earlier access to cancer therapies.

OBJECTIVES:

We aim to provide an overview of the outcomes of this emerging, fast-developing initiative.

METHODS:

A narrative literature search in electronic databases (Pubmed and Google Scholar) and grey literature was conducted to draw conclusions on how PO assessments impact oncology drugs’ access.

RESULTS:

PO is a global collaborative review program that weights the existing scientific and regulatory partnerships between various Health Technology Assessment bodies to provide a framework for concurrent submission of new oncology therapies, with the aim to enable earlier access. Currently, PO has approved 54 submissions through the FDA, leading to a significant reduction in the median time-to-approval (4.2 versus 6 months under the FDA Priority Review (FDA-PR) or 10 months under standard review). Similar reductions have been observed in other participating countries.

PO’s huge potential was first highlighted during pembrolizumab’s pilot review for the treatment of advanced endometrial carcinoma that resulted in simultaneous approval decisions in the US, Australia, and Canada. The review was completed nearly 3 months ahead of the FDA-PR deadline. Accelerated approval based on a Phase 1b/2 single-arm trial revealed the willingness of regulatory agencies to support early access to oncology treatments, despite preliminary efficacy and safety studies.

CONCLUSIONS:

Key learnings from global regulatory collaborations, such as PO, could be applied to additional countries to expediate patient access to new oncology therapies; outcomes of this initiative should be carefully considered to feed into the access strategy planning of drug manufacturers.