Oncolytics Biotech Inc T.ONC

How does Accelerated Approval work

[Noteable]

How does Accelerated Approval Work?

1. Application – standard 10-month review (unless expedited by a fast track/priority review designation) for efficacy, effectiveness, and safety.

2. Approval – FDA grants accelerated approval (prior to confirmatory trial) with specified timeline for required confirmatory trial(s) and post-market surveillance.

3. Post-accelerated approval – confirmatory studies conducted. From here, the FDA can convert the accelerated approval to a full, traditional approval if the drug confirms clinical benefit. If no clinical benefit is shown, the FDA has the regulatory authority to remove the drug from the market.

[Noteable]

Should read:  How does Accelerated Approval Work in Rare/Orphan diseases? " .... accelerated approval, which allows the use of surrogate endpoints that are not considered well established but that are determined to be “reasonably likely to predict clinical benefit.” FDA rules define surrogate endpoint as “a laboratory or physical sign that is used in therapeutic trials

[Noteable]

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit

[Noteable]

January 2024 -  FDA Unveils Groundbreaking Rare Disease Guidance Document For drugs eligible to follow the Accelerated Approval pathway, a determination of safety and effectiveness may be made based not on measures of direct clinical benefit, but rather on one of two alternative endpoints: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) an

[Noteable]

A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Likewise, an intermediate clinical endpoint is a measure of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug

[Noteable]

May 07, 2024 - “The facts clearly show the accelerated approval pathway is providing new hope and meaningful new treatments for patients to fight their disease, and why we shouldn’t be misled by biased studies that distort reality,” concludes BIO. https://www.bio.org/gooddaybio-archive/setting-record-straight-accelerated-approval May 08, 2024 - "Using a biomarker to obtain accelerated

[Noteable]

May 08, 2024 - Accelerated approval—absolutely necessary for small, pre-revenue biotechs trying to find new treatments for small patient populations. That's according to the FDA’s Peter Marks, M.D., Ph.D., who was speaking at the American Society of Gene and Cell Therapy annual meeting.

[Noteable]

"Genentech’s Tecentriq won accelerated approval in 2016 for urothelial carcinoma but failed its overall survival endpoint in a Phase III trial the following year for patients with locally advanced or metastatic urothelial cancer who had been treated with platinum chemotherapy. It was withdrawn from the market in 2021 for this indication, with additional indications being

[Noteable]

According to the FDA’s Peter Marks, M.D., Ph.D. the FDA's Accelerated Approval pathaway gives small biotech's a revenue stream to support on-boing clinical development in "orphan" and "unmet treatment need" diseases like pancreatic, breast, anal and colorectal cancers, which ONCY is currently in late stage clinical development, +/- immune checkpoint inhibitors.

[Noteable]

Should read: " ....gives small biotechs a revenue stream to support on-going clinical development ..."

[Noteable]

February 23, 2023 - European Medicines Agency (EMA) Committee for Medicianl Products for Human Use (CHMP) grants Accelerated Approval for a vaccine candidate based upon CHMP's decision that the vaccine candidate is of major interest for public health and therapeutic innovation. Logic dictates that ONCY's pelareorep candidacy for use in combination with an immune checkpoint inhibitor, in

[Quentin30]

would be of major interest... sure... but without validated biomarkers and statistically significant data relating said biomarker to OS, then NO Accelerated Approval will be forthcoming.. Not from EMA, SFDA, CFDA, FDA or Health Mongolia... ONCY have stated they will run a regular Phase III... what is your obsession with accelerated approval when ONCY management discount it themselves.. who are

[Noteable]

Simple .. AWARE-1  was a biomarker study. Biomarkers in mBC also translate to pancreatic cancer. How many more times need I point this out!

[Noteable]

https://www.prnewswire.com/news-releases/oncolytics-biotech-and-solti-achieve-primary-endpoint-in-aware-1-study-301266442.html

[Noteable]

https://www.prnewswire.com/news-releases/oncolytics-biotech-and-solti-present-further-positive-pelareorep-translational-data-at-sitc-301977019.html

[inthno]

Hello Noteable, you are posting a news release that is now almost 3 years old. The company should have been able to go ahead with the phase 3 as a result or made more progress by now as the aware 1 was specifically for the biomarkers in relation to the mbc trial. Oncolytics Biotech® and SOLTI Achieve Primary Endpoint in AWARE-1 Study News provided

[Noteable]

Blame Quentin30 who said that ONCY needed biomarkers to apply for an Accelerated Approval. So I provided the proof of ONCY's biomarker development. Don't you follow what is going on inthno OR don't you happen to understand again?

[inthno]

The only thing I do not understand is you thinking you are God and no everythng that is going on and that no one else may possibly be right or have an opinion. So tell me since you know it all, why do we not have AA as you seem to have been talking about it forever?

[Noteable]

As someone said recently.. "Don't compare me to God .. Compare me to the alternative! "

[Normandt]

You don't even understand the difference between a fact and an opinion. How can you pretend to understand Notable's explanations. Noteable responds to a false comment and responds by providing additional proofs.... and you respond that it's old news. Wake up superman! You seem more credible when you ask questions and reply to yourself in long false exchanges on yahoo or on

[Noteable]

https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-clinical-and-biomarker-data-demonstrating-clinical-proof-of-concept-for-pelareorep-checkpoint-inhibitor-combination-in-pancreatic-cancer-301295729.html

[Noteable]

https://oncolyticsbiotech.com/press_releases/oncolytics-presents-positive-updated-pancreatic-cancer-data-from-goblet-phase-1-2-study-at-esmo/

[13X2413]

Thanks for the 2021 info. Add it to the pile of useless, outdated information. 

[Azzak34]

Boooooooooo!! You stink. 

[Noteable]

ONCY's pelareorep has been granted fast track and orphan drug (rare disease) status in both pancreatic cancer and advanced/metatstatic breast cancer. In the rare disease policy space, all roads invariably lead back to the Orphan Drug Act’s (ODA) enactment. In 1983, Congress passed the ODA to amend the Food, Drug, and Cosmetic Act — the U.S. law governing the approval of medicines — to include

[Quentin30]

That's all very lovely Notable... But to get market exclusivity, you need an APPROVAL... and ONCY's key patents will start expiring in three years... is that enough time to get approval... Fast track assessment is 6 months in itself... so ONCY has 2 and a half years... and the clock is ticking... tick tock, tick tock...

[Noteable]

In the case of Orphan / Rare diseases and in diseases with unmet treatement needs, the FDA appears to have a tendency to grant  drug Accelerated Approvals much quicker than otherwise, and they do so in an overall effort to drive patients suffering from these diseases into the registration studiies earlier than could happen normally. 

[Noteable]

In the case of ONCY's biomarker driven registration studies, the number of enrolled patients for a Phase3/4 post approval confirmatory trial should be nominal due to the nature of the number of available patients with these Orphan / Rare conditions, and the urgency that having a serious cancer with an unment treatment need creates, such as with both advanced/metastatic pancreatic (PDAC) and