Talk:Accelerated approval (FDA)
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Things to add
[edit]- Move to Add Program to the article name
- How does it relate to other expedited approvals eg Fast Track, breakthrough therapy, and Orphan drug designation ? None ?
- what legislation enables this : " FDASIA in section 506(c) of the FD&C Act"[1]: 15
- what use has been made of it - which drugs (Some at [1])
- what results - how many pass or fail the phase 4 trials
- what evaluation or criticism of this program ?
- 2021 : re immunotherapy for cancer FDA’s accelerated approval program: Reevaluating the need for speed
- what are the fees or costs to apply - None?
- -- Rod57 (talk) 19:56, 18 December 2015 (UTC)
- FDA approval of Avastin for breast cancer treatment was later revoked on November 18, 2011.[2] - Rod57 (talk) 13:31, 14 January 2016 (UTC)
- Approval of a Tositumomab(Bexxar) indication was withdrawn due to lack of follow up studies.[3] - Rod57 (talk) 19:16, 18 January 2016 (UTC)
- ^ Guidance for Industry; Expedited Programs for Serious Conditions – Drugs and Biologics
- ^ FDA News Release on Avastin, retrieved 2014-04-15
- ^ GlaxoSmithKline LLC; Withdrawal of Approval of the Indication for Treatment of Patients With Relapsed or Refractory, Low Grade, Follicular, or Transformed CD20 Positive Non-Hodgkin's Lymphoma Who Have Not Received Prior Rituximab; BEXXAR
- Gemtuzumab ozogamicin was subsequently withdrawn. - Rod57 (talk) 13:09, 16 April 2016 (UTC)
- Would a case study help to emphasize the process? Ibrance was given accelerated approval in 2015 and is looked to with high hopes for metastatic breast cancer patients
- Linking to the article on the FDA Orange Book could be helpful in aiding understanding as well (https://wiki.riteme.site/wiki/Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations), as there is great information on different drug approval processes and therapeutic equivalences Rshap94 (talk) 05:01, 23 January 2017 (UTC)
Discussion of problems with AA
[edit]Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints says many cancer drugs that do not demonstrate benefits in post marketing studies remain on the market (only 1 of 8 withdrawn by FDA). Not sure how to summarise for article. - Rod57 (talk) 12:26, 28 December 2016 (UTC)
Phase 3 instead of Phase 4 studies to confirm benefit
[edit]While Phase 4 is commonly referred to as 'post-marketing studies', the studies to confirm an accelerated approval are fulfilling the criteria of phase 3 studies and are - as I understand - also referred to as Phase 3 studies. Phase 4 studies are taking place only after a successful Phase 3 study has occurred. See post marketing requirement sections of recent approval letters by FDA, for drugs receiving accelerated Approval. Wowbagger2 (talk) 10:02, 20 December 2017 (UTC) Wowbagger2 (talk) 10:02, 20 December 2017 (UTC)
Your Link [3] is in deed labeling Ph4 studies to be needed for confirmation. However, the actual [guidance|https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf] is - I guess out of purpose - not referring to neither Phase 3 nor 4. Given that accelerated approval is granted on Phase 2 (or even Phase 1) data and Phase 3 is the regular confirmatory trials, I would rather opt to describe the necessary studies as 'Phase 3 or 4'. As - in contrast to Phase IV studies - the required studies to confirm acc. approval are not only focusing on Safety. Also, only Ph3 is ensuring that a valid and necessary comparator arm is part of the study. Please note that if you search in clinical trials.gov for the respective actual studies, you also will find fhem to be labelled 'Phase 3'. Wowbagger2 (talk) 16:40, 28 December 2017 (UTC)
Dysfunct. Link
[edit]The external link on 'patient advocates' is not working. Wowbagger2 (talk) 21:03, 28 December 2017 (UTC)