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Add: doi-access. | Use this bot. Report bugs. | Suggested by Лисан аль-Гаиб | Category:AfC pending submissions by age/2 days ago | #UCB_Category 2/52
Declining submission: context - Submission provides insufficient context and nn - Submission is about a topic not yet shown to meet general notability guidelines (be more specific if possible) (AFCH 0.9.1)
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{{Short description|A new and innovative drug}}
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{{Draft topics|medicine-and-health}}

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{{AFC comment|1=It looks better than the last review, but I think there are still some issues with [[WP:NPOV]], the lack of secondary sources and, most importantly, the lack of context overall... [[User:Oltrepier|Oltrepier]] ([[User talk:Oltrepier|talk]]) 21:25, 4 November 2023 (UTC)}}
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{{AFC comment|1=Most refs are press-release or other publications by the company developing this chemical. [[WP:MEDRS]] is the relevant standard. The article itself sounds more like a press release than summarizing main ideas for encyclopedia readers, which is not an uncommon problem for writing by editors with COI (disclosed on their userpage but not here at article). All content will need to be checked for copyvio. [[User:DMacks|DMacks]] ([[User talk:DMacks|talk]]) 09:07, 23 August 2023 (UTC)}}
{{AFC comment|1=Most refs are press-release or other publications by the company developing this chemical. [[WP:MEDRS]] is the relevant standard. The article itself sounds more like a press release than summarizing main ideas for encyclopedia readers, which is not an uncommon problem for writing by editors with COI (disclosed on their userpage but not here at article). All content will need to be checked for copyvio. [[User:DMacks|DMacks]] ([[User talk:DMacks|talk]]) 09:07, 23 August 2023 (UTC)}}
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{{Short description|A new and innovative drug}}

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{{Infobox drug
{{Infobox drug
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== History ==
== History ==
In April 2023, pimicotinib has entered into a global Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the safety and efficacy of pimicotinib in patients with TGCT (NCT05804045). <ref> Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER). ''U. S. National Institutes of Health, National Cancer Institute.'' https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04443&r=1 </ref>
In April 2023, pimicotinib has entered into a global Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the safety and efficacy of pimicotinib in patients with TGCT (NCT05804045).<ref> Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER). ''U. S. National Institutes of Health, National Cancer Institute.'' https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04443&r=1 </ref>


The U.S. [[Food and Drug Administration]] (FDA) and the Center for Drug Evaluation (CDE) of [[National Medical Products Administration|NMPA]] granted pimicotinib [[breakthrough therapy]] designation (BTD) for the treatment of TGCT patients that are not amenable to surgery in January 2023 and July 2022, respectively.<ref> FDA grants breakthrough therapy designation to Abbisko’s pimicotinib. ''Global Genes.'' (2023). https://globalgenes.org/raredaily/the-u-s-food-and-drug-administration-granted-abbisko-therapeutics-breakthrough-therapy-designation-for-pimicotinib-its-experimental-therapy-for-the-treatment-of-the-rare-cancer-tenosynovial-giant-ce/ </ref>
The U.S. [[Food and Drug Administration]] (FDA) and the Center for Drug Evaluation (CDE) of [[National Medical Products Administration|NMPA]] granted pimicotinib [[breakthrough therapy]] designation (BTD) for the treatment of TGCT patients that are not amenable to surgery in January 2023 and July 2022, respectively.<ref> FDA grants breakthrough therapy designation to Abbisko’s pimicotinib. ''Global Genes.'' (2023). https://globalgenes.org/raredaily/the-u-s-food-and-drug-administration-granted-abbisko-therapeutics-breakthrough-therapy-designation-for-pimicotinib-its-experimental-therapy-for-the-treatment-of-the-rare-cancer-tenosynovial-giant-ce/ </ref>

Revision as of 21:25, 4 November 2023

  • Comment: It looks better than the last review, but I think there are still some issues with WP:NPOV, the lack of secondary sources and, most importantly, the lack of context overall... Oltrepier (talk) 21:25, 4 November 2023 (UTC)
  • Comment: Most refs are press-release or other publications by the company developing this chemical. WP:MEDRS is the relevant standard. The article itself sounds more like a press release than summarizing main ideas for encyclopedia readers, which is not an uncommon problem for writing by editors with COI (disclosed on their userpage but not here at article). All content will need to be checked for copyvio. DMacks (talk) 09:07, 23 August 2023 (UTC)
Pimicotinib
Clinical data
Other namesABSK021
Routes of
administration		Oral
Legal status
Legal status
  • Investigational
Identifiers
CAS Number
Chemical and physical data
FormulaC22H24N6O3 . HCl . H2O
Molar mass474.95 g.mol-1
3D model (JSmol)
  • Cl.O=C(NC=1N=C(C(OC2=CC=NC(=C2)C=3C=NN(C3)C)=CC1)C)N4C(=O)C(C)(C)CC4.O

Pimicotinib (ABSK021), an oral, highly potent and selective small molecule inhibitor of colony-stimulating factor 1 receptor (CSF-1R) independently discovered by Abbisko Therapeutics. A number of studies have shown that blocking the CSF-1R signaling pathway could effectively modulate and change macrophage functions, and potentially treat many macrophage-dependent human diseases.[1]

Medical uses

Pimicotinib is currently being investigated as a treatment for TGCT, chronic graft-versus-host-disease (cGVHD), and pancreatic cancer. In addition to the ongoing aforementioned clinical trials, Abbisko Therapeutics is actively exploring the potential of pimicotinib in treating many other types of solid tumors and non-oncology indications including amyotrophic lateral sclerosis (ALS).[2]

History

In April 2023, pimicotinib has entered into a global Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the safety and efficacy of pimicotinib in patients with TGCT (NCT05804045).[3]

The U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of NMPA granted pimicotinib breakthrough therapy designation (BTD) for the treatment of TGCT patients that are not amenable to surgery in January 2023 and July 2022, respectively.[4]

Soceity and culture

Pimicotinib is the first small-molecule inhibitor in Abbisko Therapeutics's pipeline that has been approved for Phase III clinical trial in both China and U.S., and it is the first CSF-1R inhibitor developed in China entering a global Phase III clinical trial.

References

  1. ^ Vaynrub A, Healey JH, Tap W, Vaynrub M (2022). "Pexidartinib in the Management of Advanced Tenosynovial Giant Cell Tumor: Focus on Patient Selection and Special Considerations". OncoTargets and Therapy. 15: 53–66. doi:10.2147/OTT.S345878. PMC 8763255. PMID 35046667.
  2. ^ ABSK-021 by Abbisko Therapeutics for pancreatic cancer: Likelihood of approval (2023). Pharmaceutical Technology. https://www.pharmaceutical-technology.com/data-insights/absk-021-abbisko-therapeutics-pancreatic-cancer-likelihood-of-approval/?cf-view
  3. ^ Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER). U. S. National Institutes of Health, National Cancer Institute. https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04443&r=1
  4. ^ FDA grants breakthrough therapy designation to Abbisko’s pimicotinib. Global Genes. (2023). https://globalgenes.org/raredaily/the-u-s-food-and-drug-administration-granted-abbisko-therapeutics-breakthrough-therapy-designation-for-pimicotinib-its-experimental-therapy-for-the-treatment-of-the-rare-cancer-tenosynovial-giant-ce/

External links

  • Clinical trial number NCT04192344 for "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor" at ClinicalTrials.gov
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