We are analyzing https://link.springer.com/article/10.1007/s40265-019-01210-0.

Title:
Pexidartinib: First Approval | Drugs
Description:
Pexidartinib (TURALIO™) is an orally administered small molecule tyrosine kinase inhibitor with selective activity against the colony-stimulating factor 1 (CSF1) receptor, KIT proto-oncogene receptor tyrosine kinase (KIT) and FMS-like tyrosine kinase 3 harboring an internal tandem duplication mutation (FLT3-ITD). In August 2019, the US FDA approved pexidartinib capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. This approval was based on positive results from the phase III ENLIVEN trial. Pexidartinib is being investigated in various malignancies as monotherapy or combination therapy. This article summarizes the milestones in the development of pexidartinib leading to its first approval for TGCT.
Website Age:
28 years and 1 months (reg. 1997-05-29).

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Keywords {🔍}

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Topics {✒️}

tenosynovial giant-cell tumor colony-stimulating factor 1 csf-1r inhibitor kit-mutated advanced acral advanced kit-mutated acral generally dose-proportional manner related plexiform neurofibromas article download pdf giant cell tumor receive open-label pexidartinib median progression-free survival treatment-emergent adverse events inhibits tumor growth generally dose-proportional pharmacokinetics pexidartinib-treated tumors compared cells harboring flt3-itd csf-1 receptor improves steady-state pexidartinib exposure protein kinase inhibitors dose-escalation extension trial gastrointestinal stromal tumor privacy choices/manage cookies receptor tyrosine kinases terminated early due csf1r inhibitor pexidartinib wild-type flt3 structure-guided blockade open-label treatment open-label extension metastatic breast cancer related subjects promote tumor growth entire development process anti-rheumatic products locally aggressive neoplasm including saint john concentration-time curve phase ib study daiichi sankyo clinically meaningful degree creative commons licence mol cancer ther patient-reported symptoms local prescribing information metastatic/advanced pancreatic tumor-bearing mice hepatic adverse reactions neurofibromatosis type advanced solid tumors liver-related teaes

Schema {🗺️}

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         description:Pexidartinib (TURALIO™) is an orally administered small molecule tyrosine kinase inhibitor with selective activity against the colony-stimulating factor 1 (CSF1) receptor, KIT proto-oncogene receptor tyrosine kinase (KIT) and FMS-like tyrosine kinase 3 harboring an internal tandem duplication mutation (FLT3-ITD). In August 2019, the US FDA approved pexidartinib capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. This approval was based on positive results from the phase III ENLIVEN trial. Pexidartinib is being investigated in various malignancies as monotherapy or combination therapy. This article summarizes the milestones in the development of pexidartinib leading to its first approval for TGCT.
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         dateModified:2020-02-28T00:00:00Z
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      headline:Pexidartinib: First Approval
      description:Pexidartinib (TURALIO™) is an orally administered small molecule tyrosine kinase inhibitor with selective activity against the colony-stimulating factor 1 (CSF1) receptor, KIT proto-oncogene receptor tyrosine kinase (KIT) and FMS-like tyrosine kinase 3 harboring an internal tandem duplication mutation (FLT3-ITD). In August 2019, the US FDA approved pexidartinib capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. This approval was based on positive results from the phase III ENLIVEN trial. Pexidartinib is being investigated in various malignancies as monotherapy or combination therapy. This article summarizes the milestones in the development of pexidartinib leading to its first approval for TGCT.
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