Pharmaceutical compound
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| Trade names | Truqap |
| Other names | AZD-5363, AZD5363 |
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| MedlinePlus | a623056 |
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| Routes of administration | By mouth |
| Drug class | Threonine kinase inhibitor |
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IUPAC name
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| ECHA InfoCard | 100.208.066  |
| Chemical and physical data | |
| Formula | C21H25ClN6O2 |
| Molar mass | 428.92 g·mol |
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Capivasertib, sold under the brand name Truqap, is an anti-cancer medication used for the treatment of breast cancer. 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. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.
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.
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. The applicant for this medicinal product is AstraZeneca AB. Capivasertib was approved for medical use in the European Union in June 2024.
References
- ^ "Truqap (capivasertib)". Therapeutic Goods Administration (TGA). 17 June 2024. Retrieved 7 July 2024.
- "Truqap (AstraZeneca Pty Ltd)". Therapeutic Goods Administration (TGA). 31 May 2024. Archived from the original on 17 June 2024. Retrieved 17 June 2024.
- "Summary Basis of Decision for Truqap". Drug and Health Products Portal. 1 September 2012. Retrieved 13 November 2024.
- ^ "Truqap- capivasertib tablet, film coated". DailyMed. 16 November 2023. Archived from the original on 20 November 2023. Retrieved 20 November 2023.
- ^ "Truqap EPAR". European Medicines Agency. 25 April 2024. Archived from the original on 30 April 2024. Retrieved 27 April 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Truqap PI". Union Register of medicinal products. 18 June 2024. Retrieved 5 July 2024.
- Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, et al. (June 2023). "Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer". New England Journal of Medicine. 388 (22): 2058–2070. doi:10.1056/NEJMoa2214131. PMC 11335038. PMID 37256976. S2CID 259002400.
- ^ "FDA approves capivasertib with fulvestrant for breast cancer". U.S. Food and Drug Administration. 16 November 2023. Archived from the original on 17 November 2023. Retrieved 17 November 2023.
This article incorporates text from this source, which is in the public domain.
- "Oncology (Cancer) / Hematologic Malignancies Approval Notifications". U.S. Food and Drug Administration. 16 November 2023. Archived from the original on 17 November 2023. Retrieved 17 November 2023.
- "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.
- ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
- AstraZeneca (26 May 2023). 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. Archived from the original on 2 August 2024. Retrieved 28 November 2024.
- "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.
External links
- 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
