Drugs / Entrectinib
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed NTRK fusion positive cancer 1 milestone | |||||
| Filed | US (FDA) | — | NTRK fusion positive cancer | 2019-01-31 | “FDA has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib” gene.com ↗ “Files for regulatory review and approval of entrectinib have been submitted to FDA.” roche.com ↗ |
| Filed RET fusion positive cancer 1 milestone | |||||
| Filed | US (FDA) | — | RET fusion positive cancer | 2019-02-18 | “FDA has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib” gene.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | ROZLYTREK | — | 2023-10-20 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Rozlytrek | — | 2020-07-31 | europa.eu ↗ |
| Approved | US (FDA) | ROZLYTREK | — | 2019-08-15 | fda.gov ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 18 trials · 1 met primary | ||||||
| Phase 1 | NCT05396859 | Oct 2022 → Jun 2024 overdue | acute myeloid leukemia | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04226833 | Feb 2020 → Sep 2021 | liver disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03961100 | Jun → Aug 2019 | cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03796260 | Jan → Feb 2019 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03330990 | Nov 2017 → Jul 2018 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03056599 | Dec 2016 → Jul 2021 | soft tissue sarcoma | Presage Biosciences | Completed | Met primary |
| Phase 1 | NCT02097810 | Jul 2014 → Jun 2020 | metastatic neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04589832 | Jan 2021 → Mar 2022 | uveal melanoma | Arkadiusz Z. Dudek, MD | Terminated | No outcome recorded Stop: Business |
| Phase 216 trials · 3 met primary | ||||||
| Phase 2 | NCT06528691 | May 2026 → Nov 2027 expected | central nervous system neoplasm, glioma | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06482086 | Jun 2021 → Dec 2024 overdue | thyroid gland carcinoma | West China Hospital | Recruiting | Met primary |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04589845 | Jan 2021 → Sep 2032 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04551495 | Jan 2021 → Jan 2025 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, invasive lobular breast carcinoma | Jules Bordet Institute | Unknown | 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 | NCT03994796 | Oct 2019 → Nov 2025 overdue | NTRK fusion positive cancer, metastatic malignant neoplasm in the brain | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03498521 | Jul 2018 → Feb 2023 | cancer of unknown primary site | Hoffmann-La Roche | Completed | Met primary |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02568267 | Nov 2015 → Jun 2027 expected | anaplastic large cell lymphoma, breast cancer, cholangiocarcinoma, colorectal cancer +10 | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02587650 | Mar 2015 → Jul 2018 | NTRK fusion positive cancer, RET fusion positive cancer, cutaneous melanoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Business |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05770544 | Nov 2025 → Oct 2029 expected | brain neoplasm, cancer, glioma, hematopoietic and lymphoid cell neoplasm +2 | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05722886 | Mar 2023 → Oct 2029 expected | cancer, hematopoietic and lymphoid cell neoplasm | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03178552 | Sep 2017 → Jun 2027 expected | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | Mixed |
| Phase 33 trials | ||||||
| Phase 3 | NCT05862285 | Jun 2023 → Mar 2033 expected | cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT05170204 | Nov 2022 → Jun 2030 expected | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04603807 | Sep 2021 → Jun 2028 expected | non-small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06195228 | Jan 2020 → Dec 2026 expected | — | Fudan University | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03066661 | — | — | Hoffmann-La Roche | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT02650401 Comparator | May 2016 → Jun 2027 expected | cancer, central nervous system neoplasm | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2022-06-09 | Hoffmann-La Roche | Regulatory U.S. FDA approves Foundation Medicine’s FoundationOne®CDx as a companion diagnostic for Roche’s Rozlytrek® (entrectinib) roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (U.S. FDA) has approved Foundation Medicine’s FoundationOne®CDx as a companion diagnostic (CDx) for Roche’s Rozlytrek® (entrectinib). |
| 2020-08-03 | Hoffmann-La Roche | Regulatory Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer roche.com ↗
The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. |
| 2020-05-29 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer roche.com ↗
The CHMP has also recommended Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. |
| 2019-08-16 | Hoffmann-La Roche | Regulatory FDA approves Roche’s RozlytrekTM (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). |
| 2019-08-15 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors gene.com ↗ |
| 2019-07-25 | Hoffmann-La Roche | Regulatory Roche reports very strong performance in the first half of 2019 – Outlook raised roche.com ↗
In Japan, the Ministry of Health, Labour and Welfare (MHLW) approved Rozlytrek (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours. |
| 2019-06-18 | Hoffmann-La Roche | Regulatory Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours. |
| 2019-05-16 | Hoffmann-La Roche | Results Roche's personalised medicine entrectinib shrank tumours harbouring NTRK, ROS1 or ALK gene fusions in children and adolescents roche.com ↗
The study showed entrectinib shrank tumours (objective response rate; ORR) in all children and adolescents who had NTRK, ROS1 or ALK fusion-positive solid tumours (11 of 11 patients), including two patients achieving a complete response. |
| 2019-05-15 | Genentech, Inc. | Results Genentech’s Personalized Medicine Entrectinib Shrank Tumors Harboring NTRK, ROS1 Or ALK Gene Fusions in Children and Adolescents gene.com ↗
The study showed entrectinib shrank tumors (objective response rate; ORR) in all children and adolescents who had NTRK, ROS1 or ALK fusion-positive solid tumors (11 of 11 patients), including two patients achieving a complete response. |
| 2019-02-19 | Hoffmann-La Roche | Regulatory FDA grants Priority Review to Roche's personalised medicine entrectinib roche.com ↗ |
| 2019-02-18 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib gene.com ↗
FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib |
| 2018-10-21 | Hoffmann-La Roche | Results Roche's investigational personalised medicine entrectinib shrank tumours in people with NTRK fusion-positive solid tumours roche.com ↗
Objective responses to entrectinib were seen across ten different solid tumour types (median duration of response [DOR]=10.4 months), including in people with and without central nervous system (CNS) metastases at baseline. |
| 2018-10-21 | Genentech, Inc. | Results Genentech’s Investigational Personalized Medicine Entrectinib Shrank Tumors in People With NTRK Fusion-Positive Solid Tumors gene.com ↗
Objective responses to entrectinib were seen across 10 different solid tumor types (median duration of response [DoR] = 10.4 months), including in people with and without central nervous system (CNS) metastases at baseline. |
| 2018-09-24 | Hoffmann-La Roche | Results Roche's investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer roche.com ↗
In addition, entrectinib demonstrated a durable response of more than two years (duration of response [DoR] = 24.6 months). |
| 2018-09-24 | Genentech, Inc. | Results Genentech’s Investigational Medicine Entrectinib Showed a Durable Response of More Than Two Years in People With a Specific Type of Lung Cancer gene.com ↗
In addition, entrectinib demonstrated a durable response of more than two years (duration of response [DoR] = 24.6 months). |
All press releases naming this drug 22 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Entrectinib | “entrectinib used outside of indication, based on biomarker” NCT04817956 ↗34“entrectinib 600 mg orally once daily” NCT06145308 ↗ |
| Known as | NMS-E628 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1983268 ↗ |
| Known as | Rozlytrek | ChEMBL registry synonym — accepted as the source's own label CHEMBL1983268 ↗ |
| Known as | RXDX-101 | “Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3),...” NCT02097810 ↗ |
| Action | Inhibit | “Entrectinib (RXDX-101) is an orally available inhibitor” NCT02097810 ↗ |
| Modality | Small molecule | “Entrectinib (RXDX-101) is an orally available tyrosine kinase inhibitor, including TrkA.” PMID 26565381 ↗ Dec 2015 |
| Route | Oral | “received entrectinib orally at a dose of at least 600 mg once per day” PMID 31838007 ↗ Dec 2019 |
| Target | ALK | “Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3),...” NCT02097810 ↗ |
| Target | NTRK1 | “Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3),...” NCT02097810 ↗ |
| Target | NTRK2 | “Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3),...” NCT02097810 ↗ |
| Target | NTRK3 | “Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3),...” NCT02097810 ↗ |
| Target | ROS1 | “Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3),...” NCT02097810 ↗ |