Chemistry:Capivasertib

From HandWiki

Capivasertib, sold under the brand name Truqap, is an anti-cancer medication used for the treatment of breast cancer.[1][2] It is taken by mouth.[1]

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.[3]

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.[3][4][5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[6] In April 2025 capivasertib, used alongside fulvestrant, was approved by the NHS in the UK.[7]

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.[1][3]

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.[3] All participants were required to have progression on aromatase inhibitor-based treatment.[3] 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.[3][8]

Society and culture

Capivasertib was approved for medical use in the United States in November 2023.[3] The FDA granted the application for capivasertib fast track designation.[6]

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.[9][10] The applicant for this medicinal product is AstraZeneca AB.[9] Capivasertib was approved for medical use in the European Union in June 2024.[9][11]

References

  1. ↑ 1.0 1.1 1.2 Cite error: Invalid <ref> tag; no text was provided for refs named Truqap FDA label
  2. ↑ "Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer". New England Journal of Medicine 388 (22): 2058–2070. June 2023. doi:10.1056/NEJMoa2214131. PMID 37256976. 
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 "FDA approves capivasertib with fulvestrant for breast cancer". 16 November 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-fulvestrant-breast-cancer.  Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ "Oncology (Cancer) / Hematologic Malignancies Approval Notifications". 16 November 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. 
  5. ↑ "Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer". AstraZeneca (Press release). 17 November 2023. Archived from the original on 17 November 2023. Retrieved 17 November 2023.
  6. ↑ 6.0 6.1 (PDF) New Drug Therapy Approvals 2023 (Report). January 2024. https://www.fda.gov/media/175253/download. Retrieved 9 January 2024. 
  7. ↑ England, N. H. S. (2025-04-11). "NHS England » Targeted breast cancer treatment approved for routine NHS use" (in en-US). https://www.england.nhs.uk/2025/04/targeted-breast-cancer-treatment-approved-for-routine-nhs-use/. 
  8. ↑ AstraZeneca (2023-05-26). 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 (Report). clinicaltrials.gov. https://clinicaltrials.gov/study/NCT04305496. Retrieved 28 November 2024. 
  9. ↑ 9.0 9.1 9.2 "Truqap EPAR". 25 April 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/truqap.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  10. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024". European Medicines Agency (Press release). 26 April 2024. Archived from the original on 5 July 2024. Retrieved 13 June 2024.
  11. ↑ "Truqap PI". 18 June 2024. https://ec.europa.eu/health/documents/community-register/html/h1820.htm. 
  • Clinical trial number NCT04305496 for "Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer (CAPItello-291)" at ClinicalTrials.gov



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