Capivasertib Explained

Tradename:Truqap
Dailymedid:Capivasertib
Pregnancy Au:D
Pregnancy Au Comment:[1]
Routes Of Administration:By mouth
Class:Threonine kinase inhibitor
Atc Prefix:L01
Atc Suffix:EX27
Legal Au:S4
Legal Au Comment:[2]
Legal Ca:Rx-only
Legal Ca Comment:[3]
Legal Us:Rx-only
Legal Us Comment:[4]
Legal Eu:Rx-only
Cas Number:1143532-39-1
Pubchem:25227436
Drugbank:DB12218
Chemspiderid:28189073
Unii:WFR23M21IE
Kegg:D11371
Chebi:229222
Chembl:2325741
Pdb Ligand:0XZ
Synonyms:AZD-5363, AZD5363
Iupac Name:4-Amino-N-[(1''S'')-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7H-pyrrolo[2,3-''d'']pyrimidin-4-yl)piperidine-4-carboxamide
C:21
H:25
Cl:1
N:6
O:2
Smiles:NC1(CCN(CC1)C1=C2C=CNC2=NC=N1)C(=O)N[C@@H](CCO)C1=CC=C(Cl)C=C1
Stdinchi:1S/C21H25ClN6O2/c22-15-3-1-14(2-4-15)17(6-12-29)27-20(30)21(23)7-10-28(11-8-21)19-16-5-9-24-18(16)25-13-26-19/h1-5,9,13,17,29H,6-8,10-12,23H2,(H,27,30)(H,24,25,26)/t17-/m0/s1
Stdinchikey:JDUBGYFRJFOXQC-KRWDZBQOSA-N

Capivasertib, sold under the brand name Truqap, is an anti-cancer medication used for the treatment of breast cancer.[5] It is taken by mouth.

The most common adverse reactions include diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting, and stomatitis.

In November 2023, capivasertib was approved in the United States for people with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer when used in combination with fulvestrant.[6] [7] [8] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]

Medical uses

Capivasertib, used in combination with fulvestrant (Faslodex), is indicated for adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within twelve months of completing adjuvant therapy.

History

Efficacy was evaluated in CAPItello-291 (NCT04305496), a randomized, double-blind, placebo-controlled, multicenter trial in 708 participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer, of which 289 participants had tumors with PIK3CA/AKT1/PTEN-alterations. All participants were required to have progression on aromatase inhibitor-based treatment. Participants could have received up to two prior lines of endocrine therapy and up to one line of chemotherapy for locally advanced or metastatic disease.[10]

Society and culture

Legal status

Capivasertib was approved for medical use in the United States in November 2023. The FDA granted the application for capivasertib fast track designation.

In April 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Truqap, intended for the treatment of locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations.[11] The applicant for this medicinal product is AstraZeneca AB.[12] Capivasertib was approved for medical use in the European Union in June 2024.[13]

Notes and References

  1. Web site: Truqap (capivasertib) . Therapeutic Goods Administration (TGA) . 17 June 2024 . 7 July 2024.
  2. Web site: Truqap (AstraZeneca Pty Ltd) . Therapeutic Goods Administration (TGA) . 31 May 2024 . 17 June 2024 . 17 June 2024 . https://web.archive.org/web/20240617031755/https://www.tga.gov.au/resources/prescription-medicines-registrations/truqap-astrazeneca-pty-ltd . live .
  3. Web site: Summary Basis of Decision for Truqap . Drug and Health Products Portal . 1 September 2012 . 13 November 2024.
  4. Web site: Truqap- capivasertib tablet, film coated . DailyMed . 16 November 2023 . 20 November 2023 . 20 November 2023 . https://web.archive.org/web/20231120050714/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d698c106-2322-401e-b738-cbd83c843ecf . live .
  5. 10.1056/NEJMoa2214131 . Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer . June 2023 . Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Park YH, Sohn J, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin EC, Grinsted L, Schiavon G, Foxley A, Rugo HS . New England Journal of Medicine . 388 . 22 . 2058–2070 . 37256976 . 259002400 . 11335038 .
  6. Web site: FDA approves capivasertib with fulvestrant for breast cancer . U.S. Food and Drug Administration . 16 November 2023 . 17 November 2023 . 17 November 2023 . https://web.archive.org/web/20231117090823/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-fulvestrant-breast-cancer . live .
  7. Web site: Oncology (Cancer) / Hematologic Malignancies Approval Notifications . U.S. Food and Drug Administration . 16 November 2023 . 17 November 2023 . 17 November 2023 . https://web.archive.org/web/20231117055636/https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications . live .
  8. Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer . AstraZeneca . 17 November 2023 . 17 November 2023 . 17 November 2023 . https://web.archive.org/web/20231117090858/https://www.astrazeneca.com/media-centre/press-releases/2023/truqap-approved-in-us-for-hr-plus-breast-cancer.html . live .
  9. New Drug Therapy Approvals 2023 . U.S. Food and Drug Administration (FDA) . January 2024 . PDF . 9 January 2024 . https://web.archive.org/web/20240110032419/https://www.fda.gov/media/175253/download . 10 January 2024 . live .
  10. A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor . AstraZeneca . 2023-05-26 . clinicaltrials.gov . NCT04305496 . 28 November 2024 . 2 August 2024 . https://web.archive.org/web/20240802124432/https://clinicaltrials.gov/study/NCT04305496 . live .
  11. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 . European Medicines Agency . 26 April 2024 . 13 June 2024 . 5 July 2024 . https://web.archive.org/web/20240705192841/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024 . live .
  12. Web site: Truqap EPAR . . 25 April 2024 . 27 April 2024 . 30 April 2024 . https://web.archive.org/web/20240430024450/https://www.ema.europa.eu/en/medicines/human/EPAR/truqap . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. Web site: Truqap PI . Union Register of medicinal products . 18 June 2024 . 5 July 2024.

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