Oncolytics Biotech Inc ONCY

RE:RE:RE:RE:RE:How does Accelerated Approval work

[Noteable]

With Replimmune leading the way on Accelerated Approval (AA) and the FDA granting Replimmune's intratumorally (IT) delivered OV therapy Breakthrough Therapy Designation (BTD), ONCY's pelareorep 'second mouse' strategy in gaining AA and BTD should lead to some very positive results from the FDA on ONCY's IV administered OV pelareorep, in particular a much earlier BTD and AA. 

 

 

 

 

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Oncolytics Biotech Inc ONCY

Primary Symbol: T.ONC

Healthcare Biotechnology

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.

 

 

Noteable - (11/22/2024 4:52:16 PM)

RE:RE:RE:RE:How does Accelerated Approval work

Fast Track and Acceleratred Approval Pathways:

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions.

The FDA Fast Track process features regular interactions with the FDA, including the potential for early and rolling review processes and the implementation of clinical trials.

The Accelerated Approval pathway allows drugs for serious conditions to be approved earlier, provided they provide a meaningful advantage over current treatments and therapies.

This pathway also allows the approval of drugs that fill a key treatment gap, using surrogate endpoints to predict clinical benefit. In these cases, drugs can be approved while confirmatory trials remain ongoing.

The Accelerated Approval pathway has brought a range of pioneering therapies in oncology and infectious diseases to market.

Accepting surrogate endpoints as a basis for approval demonstrates that the FDA recognizes the importance of balancing benefit and risk in cases where waiting for traditional endpoints could cause considerable harm to patients.

The FDA Fast Track and Accelerated Approval pathways have major implications for the wider healthcare landscape beyond drug development. 

Confirmatory trials in the case of Accelerated Approval confirm that the drug continues to offer the anticipated clinical benefit observed in the Phase 2 stage of development.