Drugs / Pralsetinib
Pralsetinib
also known as
BLU-123244 · BLU-667 · CIS-PRALSETINIB · CT-BLU667BLU-667BLU667 · GAVRETO · Pralsetinib, cis- · RG-6396 · X-581238
Small molecule targets RET via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed RET fusion positive cancer 1 milestone | |||||
| Filed | US (FDA) | — | RET fusion positive cancer | 2020-07-14 | “Blueprint Medicines has submitted a new drug application (NDA) for pralsetinib to the US Food and Drug Administration (FDA)” roche.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| Withdrawn | EU (EMA) | Gavreto | — | 2024-10-24 | europa.eu ↗ |
| Label expansion | US (FDA) | GAVRETO | — | 2023-08-09 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Gavreto | — | 2021-11-18 | europa.eu ↗ |
| Approved | US (FDA) | GAVRETO | — | 2020-09-04 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03037385 | Mar 2017 → Mar 2024 | bronchogenic carcinoma, colonic neoplasm, colorectal cancer, head and neck neoplasm +4 | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 27 trials · 2 met primary | ||||||
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06482086 | Jun 2021 → Dec 2024 overdue | thyroid gland carcinoma | West China Hospital | Recruiting | Met primary |
| Phase 2 | NCT04589845 | Jan 2021 → Sep 2032 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04632992 | Jan 2021 → Dec 2023 | cancer of unknown primary site | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04302025 | Nov 2020 → Nov 2026 expected | non-small cell lung carcinoma | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT04322890 | Apr 2020 → Dec 2026 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT04760288 | Nov 2023 → Oct 2027 | medullary thyroid gland carcinoma | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 3 | NCT04222972 | Jul 2020 → Jan 2025 | RET fusion positive cancer, adenocarcinoma, bronchogenic carcinoma, germ cell tumor +3 | Hoffmann-La Roche | Terminated | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07704658 | Jun 2026 → Jul 2027 expected | non-small cell lung carcinoma, thyroid cancer | Rigel Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 4 | NCT07010393 | Jul 2025 → Dec 2027 expected | thyroid tumor | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06195228 | Jan 2020 → Dec 2026 expected | — | Fudan University | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07418879 | Feb 2026 → Dec 2027 expected | RET fusion positive cancer, non-small cell lung carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04204928 | — | medullary thyroid gland carcinoma, non-small cell lung carcinoma | Blueprint Medicines Corporation | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-03-31 | Rigel Pharmaceuticals | Results Rigel Announces Publication of Final ARROW Clinical Trial Data on GAVRETO® (pralsetinib) in Patients with RET+ NSCLC in the Journal of Clinical Oncology rigel.com ↗
The final data includes an additional 42 months of follow-up from previously published data. |
| 2025-05-22 | Rigel Pharmaceuticals | Results Rigel Announces Poster Presentations at the 2025 ASCO Annual Meeting and EHA2025 Congress rigel.com ↗
The study data continue to demonstrate GAVRETO's clinically meaningful and durable responses in patients with RET fusion-positive NSCLC, regardless of prior therapies, with a manageable safety profile. |
| 2021-11-19 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer roche.com ↗
Gavreto is the first and only precision medicine approved in the European Union (EU) for the first-line treatment of people with RET fusion-positive advanced NSCLC. |
| 2021-09-17 | Hoffmann-La Roche | Regulatory Roche receives positive CHMP opinion for Gavreto® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer roche.com ↗ |
| 2020-12-02 | Hoffmann-La Roche | Regulatory Roche announces FDA approval of Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers roche.com ↗
These indications were approved under the FDA’s accelerated approval programme based on data from the phase I/II ARROW study. |
| 2020-12-01 | Genentech, Inc. | Regulatory Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers gene.com ↗
Gavreto is now approved across multiple RET-altered tumor types, underscoring our commitment to advancing personalized healthcare with treatments that target the underlying biology of each person’s cancer. |
| 2020-09-07 | Hoffmann-La Roche | Regulatory Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer roche.com ↗ |
| 2020-09-04 | Genentech, Inc. | Regulatory Genentech Announces FDA Approval of Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. |
All press releases naming this drug 11 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pralsetinib | “Pralsetinib etc.” NCT04322890 ↗ |
| Known as | BLU-123244 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4582651 ↗ |
| Known as | BLU-667 | “pralsetinib (BLU-667)” NCT04204928 ↗ |
| Known as | CIS-PRALSETINIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4582651 ↗ |
| Known as | CT-BLU667BLU-667BLU667 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4582651 ↗ |
| Known as | GAVRETO | ChEMBL registry synonym — accepted as the source's own label CHEMBL4582651 ↗ |
| Known as | Pralsetinib, cis- | ChEMBL registry synonym — accepted as the source's own label CHEMBL4582651 ↗ |
| Known as | RG-6396 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4582651 ↗ |
| Known as | X-581238 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4582651 ↗ |
| Action | Inhibit | “pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants” NCT03037385 ↗ |
| Modality | Small molecule | — CHEMBL4582651 ↗ |
| Route | Oral | “pralsetinib (BLU-667) administered orally” NCT03037385 ↗ |
| Target | RET | “inhibitor of the RET mutations, fusions, and predicted resistant mutants” NCT03037385 ↗ |