The FDA Oncology Center of Excellence commenced the Real-Time Oncology Review (RTOR) pilot project in February 2018 to facilitate earlier submission of topline results and datasets to support an earlier start to the FDA application review. RTOR was initially begun to support supplemental drug applications to add new indications, dosing regimens, or other clinical information to the prescribing information, but was later expanded to include original new drug applications and biological license applications for new molecular entities (NME). From February 2018 to April 2020, RTOR was used to support the submission and review of drug approvals for 20 oncology applications (11 for solid tumor and nine for hematologic malignancy indications). Two were NME drug approvals and 18 were supplemental approvals. All of the applications received priority review and nine (45%) applications had received breakthrough therapy designation status. FDA received the RTOR submissions a median of 5.7 weeks (range 1.7-16.2 weeks) prior to the full application submission. The median time from application submission to FDA approval was 3.3 months (range 0.4-5.9 months). RTOR was also integrated with other review programs including the Assessment Aid and Project Orbis programs. Innovative regulatory processes are critical to expedite the rigorous review of impactful products across the FDA.
https://www.gov.uk/guidance/guidance-on-project-orbis Products eligible for Project Orbis New marketing authorisation applications (MAAs) and new indication applications (variations) for oncology products are eligible for Project Orbis.
Selection of products to be included in Project Orbis is coordinated by the FDA, and initial queries received by participating regulatory health authorities are referred to the FDA.
Clinical criteria for FDA selection of applications for Project Orbis include high-impact and clinically significant applications. Project Orbis applications are generally expected to meet the criteria for FDA priority review. Qualifying criteria for FDA priority review include:
-the drug is intended to treat a serious condition -and if approved, would provide a significant improvement in safety or effectiveness.
Type A Applications should be submitted concurrently or near-concurrently (within 30 days) to FDA and the POPs. These are termed Type A Orbis (Regular Orbis) and allow for maximal collaboration during the review phase and the possibility of concurrent action with FDA. Type A Orbis allows for maximal collaboration during the review phase, including: -sharing of reviews -exchanging requests for clarification -participating in multi-country discussions
“We will know soon enough if in fact NWBO is paving a new pathway for immunotherapy clinical trials designs/outcomes...hence the quiet period. Change never happens quickly, especially necessary change. “
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