Replies to post #360463 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

You’ve found an outdated link.

Instead see this in May 2019 which starts to show development of RTOR beyond just supplemental indications. I’d find newer updates but I’m busy for the moment.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149609101&txt2find=Rtor

[Lykiri]

Evaluate,

Summary of Discussion Cancer Drug Development Forum (CDDF) 12th Spring Conference 2021.
Current and Future Challenges of Innovative Oncology Drugs Development.
8-10 February 2021.
Virtual Conference.
Prepared by CDDF.

Regulatory Perspective on Cancer Drug Development in a Global Setting.
R. Angelo de Claro (FDA, USA)

Even during the COVID-19 pandemic, FDA Oncology Center of Excellence (OCE) has remained highly active on several initiatives consistent with its mission to advance patient-centred regulatory decision-making through innovation and collaboration. Project Orbis, a global collaborative program launched in 2019, reported 38 approvals in its first year. Current Project Orbis partners include the regulatory health authorities of Australia, Brazil, Canada, Singapore, Switzerland, and the United Kingdom. FDA OCE reported the initial experience with the Real Time Oncology Review (RTOR) program which facilitates earlier submission of datasets to support an earlier start to the FDA application review. The median approval time was 3.3 months (range 0.4-5.9 months) for the initial set of 20 marketing applications that used RTOR (February 2018 to April 2020).
Other regulatory achievements include the issuance of 17 guidance in 2020 on many aspects of oncology drug development, including the broadening of eligibility criteria for cancer clinical trials. Patient-centred efforts include Project Community which introduces the work of the FDA to underserved communities and Project Facilitate which is a single point of contact call centre to health care providers through the expanded access request process. To facilitate interactions across multiple programs, OCE switched to virtual platforms to continue the attention on cancer drug development and to assure patients with cancer that they have not been forgotten.

P.17-18

RWE: technical perspective
Sinan Bardakci Sarac (DKMA, DK)

Q&A and Discussion

• Ultimately, drugs are developed for use in the real world. Does the lecture suggest that yet RWD will be excluded from regulatory process?
And what are the thought on using historical data from previously, or even contemporaneous, performed trials?
? What is relevant is that the data are of good and reliable quality. Pre-planned collection of RWD registries, following a specific protocol and pre-discussed with the regulators, could be acceptable.
? Indirect comparisons between trials remain difficult, and one tries to avoid this. And historical data would be hampered by the recent changes in cancer biology understanding

https://cddf.org/wp-content/uploads/2021/03/2021-CDDF-Spring-Conference-Report_Final.pdf

[Dan88]

https://clincancerres.aacrjournals.org/content/27/1/11

CCR Perspectives in Regulatory Science and Policy

U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program

R. Angelo de Claro, Jennifer J. Gao, Tamy Kim, Paul G. Kluetz, Marc R. Theoret, Julia A. Beaver and Richard Pazdur
Add to Cart ($50)

DOI: 10.1158/1078-0432.CCR-20-2220 Published January 2021

Abstract

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.

Footnotes

Clin Cancer Res 2021;27:11–4

Received June 9, 2020.
Revision received July 20, 2020.
Accepted August 17, 2020.
Published first August 19, 2020.

©2020 American Association for Cancer Research.

[ATLnsider]

Evaluate, I appreciate your reply. But, as Lykiri, Dan88 & flipper44 have said and shown, the FDA RTOR started out with only supplemental NDAs & BLAs. But, it was expanded by the FDA to include new NDAs & BLAs for NMEs.

Also, the sponsor & the FDA do not announce a RTOR submission until the new BLA / NDA application has been accepted by the FDA. This step does not happen until all of the new BLA application modules have been completely submitted.

I do not believe that NWBio has gotten this far yet. I believe that NWBio has submitted the DCVax-L top line data (TLD) to the FDA for its initial review, and the FDA has determined that the DCVax-L BLA does qualify for the FDA RTOR program, and it can be moved to the next steps in the process.

I think that is part of the reason NWBio got the loan for $11 million, was so that it hire outside experts to help them finish all the required modules to complete the new BLA, and submit it to all of the 4 regulatory authorities.

[Lykiri]

ONCOLOGY

Pedal to the metal: Assessing the FDA’s real-time oncology review program
April 23, 2019 | Article