Drugs / Larotrectinib
Larotrectinib
also known as
BAY2757556 · Vitrakvi · ARRY-470 · ARRY-470 SULFATE · larotrectinib sulfate · LOXO-101 · LOXO-101 (ARRY-470) · LOXO-101 sulfate · +1 more
Small molecule targets NTRK1, NTRK2, NTRK3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed NTRK fusion positive cancer 4 milestones | |||||
| Filed | China (NMPA) | — | NTRK fusion positive cancer | 2021-05-25 | “Bayer today announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA)” bayer.com ↗ |
| Filed | Japan (PMDA) | — | NTRK fusion positive cancer | 2020-05-22 | “Bayer has submitted an application for marketing authorization for its precision oncology treatment larotrectinib to the Ministry of Health, Labor and Welfare (MHLW) in Japan.” bayer.com ↗ |
| Filed | EU (EMA) | — | NTRK fusion positive cancer | 2018-08-27 | “the marketing authorization application (MAA) for larotrectinib has been submitted to the European Medicines Agency (EMA).” bayer.com ↗ |
| Filed | US (FDA) | — | NTRK fusion positive cancer | 2018-03-26 | “has initiated the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib.” bayer.com ↗ “has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib” bayer.com ↗ |
| Filed solid adenocarcinoma with mucin production 1 milestone | |||||
| Filed | US (FDA) | — | solid adenocarcinoma with mucin production | — | “Alembic is the sole first applicant to have filed its ANDA for Larotrectinib Capsules” alembicpharmaceuticals.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | VITRAKVI | — | 2021-03-25 – 2025-04-09 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Vitrakvi | — | 2019-09-19 | europa.eu ↗ |
| Approved | US (FDA) | VITRAKVI | — | 2018-11-26 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04655404 | Apr 2021 → Dec 2026 expected | diffuse intrinsic pontine glioma | Nationwide Children's Hospital | Recruiting | No outcome recorded |
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT03056599 | Dec 2016 → Jul 2021 | soft tissue sarcoma | Presage Biosciences | Completed | Met primary |
| Phase 1 | NCT02122913 | May 2014 → Feb 2017 | NTRK fusion positive cancer | Bayer | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07843550 | Mar → Jul 2027 expected | neoplasm | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT02637687 | Dec 2015 → Jul 2024 overdue | NTRK fusion positive cancer | Bayer | Active not recruiting | No outcome recorded |
| Phase 213 trials · 1 met primary | ||||||
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05783323 | Feb 2024 → Oct 2026 expected | childhood malignant neoplasm, differentiated thyroid carcinoma | Children's Hospital of Philadelphia | 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 | NCT05725200 | Sep 2022 → Dec 2038 expected | colorectal cancer | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06482086 | Jun 2021 → Dec 2024 overdue | thyroid gland carcinoma | West China Hospital | Recruiting | Met primary |
| Phase 2 | NCT04879121 | Apr 2021 → Nov 2027 expected | metastatic malignant neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03834961 | Oct 2019 → Sep 2024 overdue | acute leukemia, central nervous system neoplasm, pediatric fibrosarcoma | Children's Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03213704 | Aug 2017 → Sep 2024 overdue | Ewing sarcoma/peripheral primitive neuroectodermal tumor, Langerhans cell histiocytosis, ependymoma, hepatoblastoma +9 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06390852 | Aug 2017 → Apr 2023 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03155620 | Jul 2017 → Mar 2025 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, conventional osteosarcoma +13 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02576431 | Sep 2015 → Sep 2025 | NTRK fusion positive cancer | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| 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 stated1 trial | ||||||
| — | NCT03025360 | — | NTRK fusion positive cancer | Bayer | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 11th June, 2026 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Larotrectinib Capsules, 25 mg and 100 mg. |
| 2022-04-13 | Bayer | Regulatory Bayer receives approval for precision oncology treatment Vitrakvi™ in China bayer.com ↗ |
| 2021-09-16 | Bayer | Results Latest analyses of Vitrakvi (larotrectinib) reaffirm powerful efficacy and tolerability profile for both adult and pediatric patients with TRK fusion cancer bayer.com ↗
Data from four distinct analyses for Vitrakvi™ (larotrectinib) showcase its sustained clinical benefit for patients with solid tumors harboring an NTRK gene fusion (also known as TRK fusion cancer). |
| 2021-09-09 | Bayer | Results Bayer to highlight expanded research from growing oncology portfolio at ESMO Congress 2021 bayer.com ↗
Updated analyses for Vitrakvi™ (larotrectinib) reaffirm sustained clinical benefits for patients with TRK fusion cancer |
| 2021-05-25 | Bayer | Regulatory Precision oncology treatment Larotrectinib submitted for marketing authorization in China bayer.com ↗ |
| 2021-05-19 | Bayer | Results Long-term data on Vitrakvi™ (larotrectinib) confirm sustained clinical benefit of greater than four years in patients with TRK fusion cancer regardless of tumor type and age bayer.com ↗
Larotrectinib achieved 75% (95% CI 68-81) overall response rate (ORR) and median duration of response (DoR) of 49.3 months (95% CI 27.3-not estimable [NE]) |
| 2021-03-23 | Bayer | Regulatory Bayer receives approval for Vitrakvi™ in Japan bayer.com ↗
Bayer announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for larotrectinib, under the brand name Vitrakvi™, for the treatment of Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive advanced or recurrent solid tumors. |
| 2020-10-23 | Bayer | Regulatory FDA approves FoundationOne®CDx as companion diagnostic for Vitrakvi™ (larotrectinib) to aid in identifying NTRK fusion-positive patients bayer.com ↗
Bayer announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®CDx for use as the first companion diagnostic to help identify neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive patients for whom treatment with Vitrakvi™ (larotrectinib) may be appropriate. |
| 2020-09-17 | Bayer | Results New data reinforce strong clinical profile of Vitrakvi™ for patients of all ages with TRK Fusion Cancer including lung and thyroid tumors bayer.com ↗
In addition, new tumor-type specific sub-analyses in lung and thyroid cancer patients further emphasize these durable responses while showing a favorable safety profile. |
| 2020-05-29 | Bayer | Results Efficacy of Vitrakvi™ further established with continued high response rates and durable response in updated analyses in adult patients and quality of life data in adult and pediatric patients bayer.com ↗
Updated clinical data for Vitrakvi™ (larotrectinib) show continued high response rates and duration of response with longer follow-up and favorable safety in an expanded data set of 116 adult patients with TRK fusion cancer, including those with brain metastases. |
| 2020-05-22 | Bayer | Regulatory Bayer submits larotrectinib for marketing authorization in Japan for the treatment of TRK fusion cancer bayer.com ↗
Bayer has submitted an application for marketing authorization for its precision oncology treatment larotrectinib to the Ministry of Health, Labor and Welfare (MHLW) in Japan. |
| 2019-09-28 | Bayer | Results Updated analysis for larotrectinib confirms high response rate and durable responses over three years in children and adults with TRK fusion cancer bayer.com ↗
Updated clinical data for larotrectinib in adult and pediatric patients with TRK fusion cancer showed a high response rate with an overall response rate (ORR) of 79% (95% CI: 72-85) with 16% complete responses (n=24) and 63% partial responses (n=97). |
| 2019-09-23 | Bayer | Regulatory Vitrakvi® (larotrectinib) receives first tumor-agnostic approval in EU bayer.com ↗
Bayer today announced that the European Commission has granted marketing authorization in the European Union (EU) for the precision oncology treatment Vitrakvi® (larotrectinib). |
| 2019-07-26 | Bayer | Regulatory Bayer receives positive CHMP opinion for precision oncology treatment larotrectinib with first ever tumor-agnostic indication in in Europe bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended Bayer’s precision oncology treatment larotrectinib for marketing authorization in the European Union (EU). |
| 2019-06-03 | Bayer | Results New data on larotrectinib efficacy in patients with TRK fusion cancer and primary CNS tumors or brain metastases presented at ASCO 2019 bayer.com ↗
In evaluable patients with NTRK gene fusion positive solid tumors with brain metastases (n=5), the ORR was 60% (n=3 PRs; 95% CI: 15-95), and stable disease was achieved in 40% (n=2) of patients. |
| 2019-05-15 | Bayer | Results New data for larotrectinib show overall response rates of 94% in children and 76% in adults with TRK fusion cancer; clinical benefit demonstrated in primary CNS tumors and brain metastases bayer.com ↗
Bayer today announced findings from new analyses for larotrectinib, showing an overall response rate (ORR) of 94% in children with TRK fusion cancer, with median duration of response (DOR) not reached at the time of data cut-off (July 30, 2018). |
| 2018-11-27 | Bayer | Regulatory U.S. FDA approves Larotrectinib, the first TRK inhibitor, for patients with advanced solid tumors harboring an NTRK gene fusion bayer.com ↗
The U.S. Food and Drug Administration (FDA) has approved larotrectinib, the first oral TRK inhibitor, under the brand name Vitrakvi®. |
| 2018-10-21 | Bayer | Results Expanded larotrectinib data confirm findings on efficacy and safety in adult and pediatric patients with TRK fusion cancer across various tumor types bayer.com ↗
Results from an expanded dataset from clinical trials with larotrectinib, an investigational oral, CNS-active tropomyosin receptor kinase (TRK) inhibitor, in patients with TRK fusion cancer showed continued robust antitumor activity across different tumor types and in both adults and children. |
| 2018-08-27 | Bayer | Regulatory Bayer submits European marketing authorization application for larotrectinib for the treatment of TRK fusion cancer bayer.com ↗
Bayer announced today that the marketing authorization application (MAA) for larotrectinib has been submitted to the European Medicines Agency (EMA). |
| 2018-05-29 | Bayer | Regulatory U.S. FDA accepts larotrectinib New Drug Application and grants priority review bayer.com ↗
The Priority Review designation for larotrectinib may help bring this treatment option to patients, facing a high unmet medical need, as soon as possible. |
| 2018-03-26 | Bayer | Regulatory Bayer announces completion of rolling submission of New Drug Application in the U.S. for larotrectinib for the treatment of TRK fusion cancer bayer.com ↗ |
| 2017-12-20 | Bayer | Regulatory Bayer announces initiation of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancers bayer.com ↗
The NDA is being submitted for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments. |
| 2017-12-04 | Bayer | Results Updated larotrectinib pediatric clinical trial data demonstrate continued durability of response in TRK fusion cancers bayer.com ↗
Bayer and Loxo Oncology, Inc., a biopharmaceutical company based in Stamford, Connecticut, US, (NASDAQ: LOXO), today announced updated clinical data from the larotrectinib (LOXO-101) pediatric Phase I SCOUT trial (NCT02637687). |
All press releases naming this drug 24 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Larotrectinib | “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗20“larotrectinib 100 mg orally twice daily” NCT06145308 ↗ |
| Known as | ARRY-470 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | ARRY-470 SULFATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | BAY2757556 | “Larotrectinib (Vitrakvi, BAY2757556)” NCT03025360 ↗3“Larotrectinib (Vitrakvi, BAY2757556)” NCT02122913 ↗ “Larotrectinib (Vitrakvi, BAY2757556)” NCT02637687 ↗ “BAY2757556 (Larotrectinib, Vitrakvi)” NCT02576431 ↗ |
| Known as | larotrectinib sulfate | “Patients receive larotrectinib sulfate orally (PO) or via nasogastric (NG)- or gastric (G)-tube twice per day (BID) on days 1-28.” NCT03213704 ↗ |
| Known as | LOXO-101 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | LOXO-101 (ARRY-470) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | LOXO-101 sulfate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | LOXO-101LOXO 101LOXO101A-9048 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | Vitrakvi | “Larotrectinib (Vitrakvi, BAY2757556)” NCT02637687 ↗3“Larotrectinib (Vitrakvi, BAY2757556)” NCT03025360 ↗ “Larotrectinib (Vitrakvi, BAY2757556)” NCT02122913 ↗ “BAY2757556 (Larotrectinib, Vitrakvi)” NCT02576431 ↗ |
| Action | Inhibit | “because it blocks the action of these genes in cancer cells” NCT02122913 ↗ |
| Modality | Small molecule | “Larotrectinib, a highly selective small-molecule inhibitor of the TRK kinases” PMID 29606586 ↗ Mar 2018 |
| Route | Oral | “receive larotrectinib (LOXO-101) PO BID” NCT02465060 ↗ |
| Target | NTRK1 | “The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells.” NCT02122913 ↗ |
| Target | NTRK2 | “The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells.” NCT02122913 ↗ |
| Target | NTRK3 | “The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells.” NCT02122913 ↗ |