Pralsetinib
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Trade names | Gavreto |
Other names | BLU-667 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a620057 |
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Routes of administration | By mouth |
Drug class | Tyrosine kinase inhibitor |
ATC code | |
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Pralsetinib, sold under the brand name Gavreto, is a medication approved[10] for RET mutation-positive medullary thyroid cancer (MTC)[11] and RET fusion-positive differentiated thyroid cancer (DTC) refractory to radioactive iodine (RAI) therapy.[12] Pralsetinib is a tyrosine kinase inhibitor. It is taken by mouth.[12]
The most common adverse reactions include increased
Pralsetinib was approved for medical use in the United States in September 2020,[12][13][14][15][16][excessive citations] and in the European Union in November 2021.[8]
Medical uses
Pralsetinib is indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.[12][15]
History
Efficacy was investigated in a multicenter, open-label, multi-cohort clinical trial (ARROW, NCT03037385) with 220 participants aged 26-87 whose tumors had RET alterations.[12][15] Identification of RET gene alterations was prospectively determined in local laboratories using either next generation sequencing, fluorescence in situ hybridization, or other tests.[12] The main efficacy outcome measures were overall response rate (ORR) and response duration determined by a blinded independent review committee using RECIST 1.1.[12] The trial was conducted at sites in the United States, Europe and Asia.[15]
Efficacy for RET fusion-positive NSCLC was evaluated in 87 participants previously treated with platinum chemotherapy.[12] The ORR was 57% (95% CI: 46%, 68%); 80% of responding participants had responses lasting 6 months or longer.[12] Efficacy was also evaluated in 27 participants who never received systemic treatment.[12] The ORR for these participants was 70% (95% CI: 50%, 86%); 58% of responding participants had responses lasting 6 months or longer.[12]
The US Food and Drug Administration (FDA) granted the application for pralsetinib priority review, orphan drug, and breakthrough therapy designations[12]and granted approval of Gavreto to Blueprint Medicines.[12]
Society and culture
Legal status
On 16 September 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Gavreto, intended for the treatment of people with rearranged during transfection (RET)-fusion positive non-small cell lung cancer (NSCLC).[17] The applicant for this medicinal product is Roche Registration GmbH.[17] Pralsetinib was approved for medical use in the European Union in November 2021.[8]
References
- ^ a b "Gavreto". Therapeutic Goods Administration (TGA). 6 April 2023. Archived from the original on 8 April 2023. Retrieved 7 April 2023.
- ^ "Gavreto pralsetinib 100 mg hard capsule bottle (380812)". Therapeutic Goods Administration (TGA). 30 March 2023. Archived from the original on 8 April 2023. Retrieved 7 April 2023.
- ^ "Gavreto (Roche Products Pty Ltd)". Therapeutic Goods Administration (TGA). 26 April 2023. Retrieved 28 April 2023.
- ^ "Gavreto (Roche Products Pty Ltd)". Therapeutic Goods Administration (TGA). 26 April 2023. Retrieved 28 April 2023.
- ^ https://www.tga.gov.au/resources/auspar/auspar-gavreto-0
- ^ "Summary Basis of Decision (SBD) for Gavreto". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
- ^ "Gavreto- pralsetinib capsule". DailyMed. 9 September 2020. Archived from the original on 28 November 2020. Retrieved 24 September 2020.
- ^ a b c "Gavreto EPAR". European Medicines Agency (EMA). 14 September 2021. Archived from the original on 10 December 2021. Retrieved 9 December 2021.
- ^ "Gavreto Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
- ^ "FDA approves pralsetinib for RET-altered thyroid cancers". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. 11 June 2021. Archived from the original on 9 January 2023. Retrieved 9 January 2023.
- PMID 36275786.
- ^ a b c d e f g h i j k l m n "FDA approves pralsetinib for lung cancer with RET gene fusions". U.S. Food and Drug Administration (FDA). 4 September 2020. Archived from the original on 9 September 2020. Retrieved 8 September 2020. This article incorporates text from this source, which is in the public domain.
- ^ "Blueprint Medicines Announces FDA Approval of Gavreto (pralsetinib) for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer" (Press release). Blueprint Medicines. 4 September 2020. Archived from the original on 9 September 2020. Retrieved 8 September 2020 – via PR Newswire.
- ^ "Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer". Roche (Press release). 7 September 2020. Archived from the original on 9 September 2020. Retrieved 8 September 2020.
- ^ a b c d "Drug Trial Snapshot: Gavreto". U.S. Food and Drug Administration. 4 September 2020. Archived from the original on 25 October 2020. Retrieved 16 September 2020. This article incorporates text from this source, which is in the public domain.
- S2CID 226223522.
- ^ a b "Gavreto: Pending EC decision". European Medicines Agency. 17 September 2021. Archived from the original on 17 September 2021. Retrieved 17 September 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
External links
- "Pralsetinib". NCI Drug Dictionary. National Cancer Institute.
- Clinical trial number NCT03037385 for "Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors (ARROW)" at ClinicalTrials.gov
- "Understanding Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)" (PDF).
- "Understanding Metastatic RET-Driven Thyroid Cancers" (PDF).