GAVRETO® (Pralsetinib), 100 mg hard capsules
Swissmedic marketing authorisation number: 68182
Swissmedic marketing authorisation date: 12.08.2021
Marketing authorisation studies (1):
Indications: RET fusion-positive non-small cell lung cancer (NSCLC), medullary thyroid carcinoma (MTC) with RET mutation or RET fusion-positive thyroid carcinoma in adult patients with advanced, metastatic disease who require systemic therapy and who have experienced progression after previous treatment.
Summary: Pivotal phase I/II, first-in-human, open-label study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of pralsetinib in adult patients with advanced unresectable RET fusion-driven NSCLC, RET mutation or RET fusion-driven thyroid carcinoma and other solid tumors with RET fusions. The study included a phase I dose escalation part to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of pralsetinib.
Following the phase I part of the study, a phase II expansion part followed with the aim of evaluating the clinical efficacy based on the primary endpoint and secondary endpoints in specific tumour entities, as well as the safety and tolerability of pralsetinib.
Sponsor: Blueprint Medicines
- 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).https://clinicaltrials.gov/ct2/show/NCT03037385
- Gainor et al., Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncology, 2021 Jul;22(7):959-969
- Subbiah et al., Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected new or serious adverse reactions. Please see Fachinformation GAVRETO® on www.swissmedicinfo.ch. for more information.
Publication of clinical trial results
The above information and the links provided to clinical data comply with the requirements of Articles 71-73 of the Ordinance on Medicinal Products (VAM) and complement the information published in connection with the Swiss marketing authorisation of Gavreto. Articles 71-73 VAM apply to all medicinal products submitted and authorised by Swissmedic as of January 2019.
The published data supports physicians and other healthcare providers in making informed treatment decisions and allows researchers to more easily base their research on that conducted by Roche and its partners, as well as that conducted by other researchers, in order to drive scientific progress.