Drugs / Binimetinib
Binimetinib
also known as
MEK162 · ARRY-438162 · BIN · ARRY-162 · Bini · MEK162/ARRY-438162 · MEKTOVI · NVP-MEK162
Small molecule targets MAP2K1, MAP2K2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 1 milestone | |||||
| Filed | US (FDA) | MEKTOVI | non-small cell lung carcinoma | 2023-04-04 | “FDA has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI ® (encorafenib) + MEKTOVI ® (binimetinib) for patients with metastatic non-small cell lung cancer” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | MEKTOVI | — | 2019-01-23 – 2025-03-12 | fda.gov ↗ |
| Approved | EU (EMA) | Mektovi | — | 2018-09-20 | europa.eu ↗ |
| Approved | US (FDA) | MEKTOVI | — | 2018-06-27 | fda.gov ↗ |
Trials 127 · started per year
today
US approved 2018
EU approved 2018
1
1
5
5
10
7
5
9
7
7
12
12
21
11
7
5
2
20082009201020112012201320142015201620172018201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04870034 | Jan 2024 → Sep 2025 | colorectal carcinoma, lung adenocarcinoma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT04741997 | May 2021 → Apr 2027 expected | metastatic melanoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 0 | NCT03543969 | Jun 2018 → Dec 2024 overdue | cutaneous melanoma, skin carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 135 trials · 1 missed | ||||||
| Phase 1 | NCT05111561 | Aug 2022 → Mar 2027 | metastatic malignant neoplasm, triple-negative breast carcinoma | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 1 | NCT05355701 | Jul 2022 → Aug 2027 expected | colorectal cancer, glioma, melanoma, non-small cell lung carcinoma +1 | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04965818 | Sep 2021 → Jun 2023 | non-small cell lung carcinoma | Taiho Oncology, Inc. | Terminated | Missed primary Stop: Business |
| Phase 1 | NCT05103891 | Sep → Nov 2021 | metastatic melanoma | Pierre Fabre Laboratories | Unknown | No outcome recorded |
| Phase 1 | NCT04913285 | Aug 2021 → Nov 2028 expected | melanoma, non-small cell lung carcinoma | Pierre Fabre Laboratories | Recruiting | No outcome recorded |
| Phase 1 | NCT04892017 | Jun 2021 → Mar 2026 | metastatic neoplasm, non-small cell lung carcinoma | Deciphera Pharmaceuticals, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04800822 | Mar 2021 → Jun 2024 | neoplasm | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04759846 | Jan 2021 → May 2023 | metastatic melanoma | Pierre Fabre Laboratories | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04543188 | Jan 2021 → Mar 2024 | melanoma, non-small cell lung carcinoma, primary brain neoplasm | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04044430 | Aug 2020 → Jul 2022 | colon adenocarcinoma, rectum adenocarcinoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03878719 | Aug 2020 → Aug 2022 | melanoma | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04005144 | Feb 2020 → Oct 2022 | non-small cell lung carcinoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04132505 | Oct 2019 → Mar 2026 | pancreatic adenocarcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03991819 | Sep 2019 → Aug 2026 overdue | non-small cell lung carcinoma | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03374254 | Feb 2018 → Sep 2021 | colorectal cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT03170206 | May 2017 → Feb 2023 | lung cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT03158103 | Apr 2017 → Apr 2021 | gastrointestinal stromal tumor | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02964689 | Apr 2017 → Jul 2021 | non-small cell lung carcinoma | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02185690 | Mar 2017 → Jul 2019 | lung cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1 | NCT02613650 | Aug 2016 → Nov 2022 | colorectal cancer | University of Utah | Completed | No outcome recorded |
| Phase 1 | NCT02451865 | Jun 2016 → Jun 2018 | non-small cell lung carcinoma | Jonsson Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT02105350 | Jun 2015 | biliary tract cancer, gallbladder carcinoma | University Health Network, Toronto | Withdrawn | No outcome recorded |
| Phase 1 | NCT02225574 | Mar 2015 → Feb 2017 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02049801 | Dec 2014 → Feb 2015 | acute erythroid leukemia, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation, acute myeloid leukemia with 11q23 abnormalities +7 | Bruno C. Medeiros | Terminated | No outcome recorded |
| Phase 1 | NCT02510001 | Nov 2014 → Dec 2018 | colorectal cancer | University of Oxford | Completed | No outcome recorded |
| Phase 1 | NCT02041481 | Jun 2014 → Jan 2018 | malignant colon neoplasm, rectal cancer | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02050815 | Mar 2014 → Aug 2016 | — | Array BioPharma | Terminated | No outcome recorded |
| Phase 1 | NCT01859026 | Dec 2013 → Aug 2019 | non-small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01649336 | Jul 2012 → Mar 2016 | fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer | Array BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT01449058 | Mar 2012 → Aug 2016 | acute myeloid leukemia, myelodysplastic syndrome | Array BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT01469130 | Nov 2011 → Apr 2014 | neoplastic disease or syndrome | Array BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT01363232 | Aug 2011 → Mar 2014 | cancer | Array BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT01337765 | Jul 2011 → Mar 2013 | cancer of unknown primary site | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01352273 | Jun 2011 → Sep 2013 | cancer | Array BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT00959127 | Aug 2009 → Jan 2013 | biliary tract cancer, colorectal cancer | Array BioPharma | Completed | No outcome recorded |
| Phase 1/223 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT05340621 | May 2022 → Jan 2025 | RASopathy, melanoma | OnKure, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05080621 | Nov 2021 → Nov 2025 | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04655157 | May 2021 → Aug 2022 | melanoma | Jason J. Luke, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04720976 | Mar 2021 → Dec 2023 | non-small cell lung carcinoma | Allist Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04494958 | Nov 2020 → Dec 2023 | triple-negative breast carcinoma | Fundacion Oncosur | Completed | Missed primary |
| Phase 1/2 | NCT04585815 | Nov 2020 → May 2023 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04720768 | Jun 2020 → Dec 2024 | melanoma, metastatic neoplasm | Peter MacCallum Cancer Centre, Australia | Unknown | No outcome recorded |
| Phase 1/2 | NCT04292119 | May 2020 → Dec 2022 | non-small cell lung carcinoma, refractory malignant neoplasm | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03947385 | Jun 2019 → Jan 2027 expected | colorectal cancer, cutaneous melanoma, uveal melanoma | IDEAYA Biosciences | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03843775 | Feb 2019 → Sep 2023 | neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03637491 | Aug 2018 → Dec 2020 | pancreatic ductal adenocarcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT02902042 | Apr 2018 → Nov 2020 | melanoma | Prof. Dr. med. Dirk Schadendorf | Completed | No outcome recorded |
| Phase 1/2 | NCT03106415 | Sep 2017 → May 2022 | breast adenocarcinoma, triple-negative breast carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT02285439 | May 2016 → Nov 2022 | brain cancer, low grade glioma, soft tissue neoplasm | Children's Hospital Los Angeles | Completed | No outcome recorded |
| Phase 1/2 | NCT02773459 | Apr 2016 → Jan 2019 | biliary tract cancer | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT02089230 | Aug 2014 → Jun 2019 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01927341 | Nov 2013 → Jan 2016 | colorectal cancer | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT01991379 | Nov 2013 → Nov 2026 expected | gastrointestinal stromal tumor | Memorial Sloan Kettering Cancer Center | Active not recruiting | Met primary |
| Phase 1/2 | NCT01801358 | Aug 2013 → May 2015 | uveal melanoma | Array BioPharma | Terminated | No outcome recorded |
| Phase 1/2 | NCT01781572 | Jun 2013 → Jan 2018 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT01828034 | Apr 2013 → May 2019 | biliary tract cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01562899 | Aug 2012 → Apr 2015 | pancreatic adenocarcinoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01543698 | May 2012 → Mar 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 255 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT06887088 | May 2025 → Jan 2028 expected | melanoma | Spanish Melanoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05554354 | Sep 2024 → Apr 2025 | female breast carcinoma, hormone receptor-positive breast cancer | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06207656 | Apr 2024 → Apr 2029 expected | colorectal cancer | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | Recruiting | No outcome recorded |
| Phase 2 | NCT05564403 | Feb 2024 → Oct 2026 expected | distal biliary tract carcinoma, gallbladder carcinoma, hilar cholangiocarcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05554367 | Dec 2023 → Aug 2026 overdue | exocrine pancreatic carcinoma, ovarian serous adenocarcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06229340 | Oct 2023 → Oct 2026 expected | colorectal cancer, lung cancer, malignant pancreatic neoplasm, melanoma +1 | N.N. Petrov National Medical Research Center of Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT05304546 | Sep 2023 → Jul 2025 | metastatic melanoma | Dr. Ronnie Shapira | Completed | No outcome recorded |
| Phase 2 | NCT05926960 | Jun 2023 → Feb 2026 | melanoma | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05286788 | Apr 2023 → Apr 2027 expected | adamantinous craniopharyngioma | Nationwide Children's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05564377 | Apr 2023 → Jul 2030 expected | Her2-receptor negative breast cancer, endometrial carcinoma, fallopian tube carcinoma, female breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06159478 | Mar 2023 → Feb 2027 expected | low grade glioma, malignant pancreatic neoplasm | National Cancer Center, Japan | Recruiting | No outcome recorded |
| Phase 2 | NCT04074096 | Sep 2022 → May 2026 overdue | melanoma, metastatic malignant neoplasm in the brain | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05510895 | Sep 2022 → Jul 2024 | colon carcinoma | AIO-Studien-gGmbH | Completed | No outcome recorded |
| Phase 2 | NCT05195632 | Jun 2022 → May 2024 overdue | non-small cell lung carcinoma | Pierre Fabre Laboratories | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05097378 | Jan 2022 → Sep 2023 | cancer, melanoma | CCTU- Cancer Theme | Unknown | No outcome recorded |
| Phase 2 | NCT05767879 | Jan 2022 → Jan 2026 | cutaneous melanoma | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT05026983 | Dec 2021 → Feb 2027 expected | cutaneous melanoma, metastatic melanoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05170334 | Dec 2021 → Dec 2025 overdue | uveal melanoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04221438 | Sep 2021 → Jun 2024 | cutaneous melanoma, metastatic malignant neoplasm in the lymph nodes | ECOG-ACRIN Cancer Research Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04735068 | Apr 2021 → Aug 2022 | non-small cell lung carcinoma | Abramson Cancer Center at Penn Medicine | Completed | Missed primary |
| Phase 2 | NCT04598009 | Mar 2021 → May 2027 expected | melanoma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2 | NCT04526782 | Jan 2021 → Jul 2025 overdue | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04322383 | Jan 2021 → Apr 2028 expected | hairy cell leukemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT04511013 | Jan 2021 → Jun 2027 expected | acral lentiginous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma, mucosal melanoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT04375527 | Dec 2020 → Nov 2024 | cutaneous melanoma | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04390243 | Nov 2020 → Nov 2023 | digestive system carcinoma, metastatic carcinoma | Academic and Community Cancer Research United | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04061980 | Oct 2020 → Dec 2027 expected | differentiated thyroid carcinoma | Providence Health & Services | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04324112 | Oct 2020 → May 2026 overdue | hairy cell leukemia | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03981614 | Oct 2019 → Aug 2021 | colorectal carcinoma | Academic and Community Cancer Research United | Completed | No outcome recorded |
| Phase 2 | NCT03973918 | Jul 2019 → Apr 2022 | anaplastic astrocytoma, anaplastic pleomorphic xanthoastrocytoma, gliosarcoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 2 | NCT03898908 | Jul 2019 → Oct 2022 | metastatic malignant neoplasm in the brain, metastatic melanoma | Spanish Melanoma Group | Completed | No outcome recorded |
| Phase 2 | NCT03971409 | Jul 2019 → Jan 2027 expected | female breast carcinoma, invasive breast carcinoma, triple-negative breast carcinoma | Laura Huppert, MD, BA | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03839342 | Jun 2019 → Dec 2026 expected | cancer | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03915951 | Jun 2019 → Sep 2022 | non-small cell lung carcinoma | Pfizer | Completed | Met primary |
| Phase 2 | NCT03911869 | Apr 2019 → Jan 2022 | metastatic malignant neoplasm in the brain | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03693170 | Jan 2019 → Jun 2020 | — | Pierre Fabre Laboratories | Completed | Met primary |
| Phase 2 | NCT03235245 | Oct 2018 → Oct 2023 overdue | melanoma | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | Missed primary |
| Phase 2 | NCT03475004 | Sep 2018 → Apr 2022 | colorectal cancer, metastatic malignant neoplasm | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT03563729 | Jun 2018 → Jun 2024 overdue | melanoma | Inge Marie Svane | Recruiting | No outcome recorded |
| Phase 2 | NCT03231306 | Nov 2017 → Apr 2024 | neurofibromatosis type 1, plexiform neurofibroma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT03271047 | Oct 2017 → Oct 2020 | colorectal cancer | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02910700 | Dec 2016 → Dec 2027 expected | cutaneous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02631447 | Nov 2016 → May 2024 | metastatic melanoma | Fondazione Melanoma Onlus | Completed | Met primary |
| Phase 2 | NCT02834364 | Jun 2016 → Mar 2023 | refractory plasma cell neoplasm | University of Heidelberg Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04439344 | May 2016 → May 2019 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | 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 2 | NCT02276027 | Jan 2015 → Oct 2019 | lung adenocarcinoma, squamous cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02263898 | Jan 2015 → Dec 2019 | metastatic melanoma | Jonsson Comprehensive Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02159066 | Jul 2014 → Jan 2023 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02094872 | May 2014 → Dec 2018 | melanoma | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT01885195 | Oct 2013 → Oct 2015 | hematopoietic and lymphoid cell neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01556568 | Feb 2012 → May 2017 | — | Array BioPharma | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01320085 | Mar 2011 → Jan 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00650767 | Mar 2008 → Jul 2009 | rheumatoid arthritis | Array BioPharma | Completed | No outcome recorded |
| Phase 38 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05270044 | May 2022 → Mar 2027 expected | melanoma | Pierre Fabre Laboratories | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04657991 | Jan 2021 → Oct 2026 expected | melanoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03803553 | Apr 2020 → Dec 2026 expected | metastasis from malignant tumor of colon | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02928224 | Oct 2016 → Feb 2019 | — | Pfizer | Completed | Met primary |
| Phase 3 | NCT01909453 | Sep 2013 → Nov 2016 | melanoma | Pfizer | Completed | Met primary |
| Phase 3 | NCT01763164 | Jul 2013 → Dec 2015 | cutaneous melanoma | Pfizer | Completed | Met primary |
| Phase 3 | NCT01849874 | Jun 2013 → Jan 2016 | fallopian tube serous adenocarcinoma, malignant ovarian serous tumor, primary peritoneal serous adenocarcinoma | Pfizer | Terminated | Missed primary Stop: Enrollment |
| Phase 42 trials | ||||||
| Phase 4 | NCT07092410 | Aug 2025 → Aug 2030 | melanoma | SRH Wald-Klinikum Gera GmbH | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05203172 | Jul 2022 → Jul 2029 expected | cancer | Pfizer | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT04903119 Background | Jun 2022 → Jul 2028 expected | metastatic melanoma | Rina Plattner | Recruiting | No outcome recorded |
| Phase 1 | NCT03864042 Background | Jan 2018 → Jul 2022 | cancer, metastatic melanoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT06470880 Comparator | Jun 2024 → Jun 2026 overdue | melanoma | The Christie NHS Foundation Trust | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05370807 Background | Oct 2022 → Dec 2026 expected | metastatic melanoma | University Hospital Brussels | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 19th 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) Binimetinib Tablets, 45 mg. |
| 2025-10-19 | Pfizer | Results Pfizer’s BRAFTOVI® + MEKTOVI® Shows Sustained Long-Term Survival in Patients with Advanced Lung Cancer pfizer.com ↗
In treatment-naïve patients, the median overall survival (OS) was 47.6 months (95% confidence interval [CI], 31.3, not estimable) after a median follow-up of 52.3 months. |
| 2024-09-14 | Pfizer | Results Pfizer’s BRAFTOVI® + MEKTOVI® Shows Long-Term Clinically Meaningful Response in Patients with BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from the Phase 2 single-arm PHAROS clinical trial evaluating the efficacy and safety of BRAFTOVI ® (encorafenib) in combination with MEKTOVI ® (binimetinib) for patients with BRAF V600E - mutant metastatic non-small cell lung cancer (NSCLC). |
| 2024-05-17 | Ono Pharmaceutical Co., Ltd. | Regulatory Ono Receives Approvals of BRAFTOVI® and MEKTOVI® for Expanded Use for Two New Indications in Japan ono-pharma.com ↗
These approvals are based on the results of a Phase 2 study (ONO-7702/7703-03), conducted in Japan in 22 patients with unresectable BRAF V600 -mutant thyroid cancer, including 5 patients with anaplastic thyroid cancer. |
| 2024-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approval dated 9th May, 2024 alembicpharmaceuticals.com ↗
This is to inform the exchanges that the Company has received various US Food & Drug Administration (USFDA) (Tentative or Final) Product Approvals. |
| 2023-10-23 | IDEAYA Biosciences | Results IDEAYA Announces Top-Line Phase 2 Results at ESMO 2023 of Darovasertib and Crizotinib Combo in MUM, and Clinical Efficacy Updates for Neoadjuvant UM, GNAQ/11 Cutaneous Melanoma, and Synthetic Lethality Pipeline ideayabio.com ↗
1 of 2 cutaneous melanoma patients with a PR demonstrated 50% tumor shrinkage and remained on treatment approximately 600 days after previously receiving multiple prior lines of immunotherapy |
| 2023-10-12 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s BRAFTOVI® + MEKTOVI® for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI ® (encorafenib) + MEKTOVI ® (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. |
| 2023-05-31 | Ono Pharmaceutical Co., Ltd. | Regulatory ONO Submits Supplemental Applications for Approval of BRAFTOVI® Capsule and MEKTOVI® Tablet in Japan for the Treatment of Radically Unresectable BRAF-Mutant Thyroid Cancer ono-pharma.com ↗ |
| 2023-04-04 | Pfizer | Regulatory FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI ® (encorafenib) + MEKTOVI ® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. |
| 2022-06-03 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for FoundationOne CDx Cancer Genomic Profile to be Used as Companion Diagnostic of Four Drugs for the Treatment of Non-Small Cell Lung Cancer and Malignant Melanoma chugai-pharm.co.jp ↗
for malignant melanoma therapies, a BRAF inhibitor BRAFTOVI ® capsules (generic name: encorafenib) and a MEK inhibitor MEKTOVI ® tablets (generic name: binimetinib) |
| 2021-04-16 | IDEAYA Biosciences | Results IDEAYA Reports Darovasertib (IDE196) Monotherapy Overall Survival Data and Observes Early Partial Responses in Binimetinib Combination in Metastatic Uveal Melanoma ideayabio.com ↗ |
| 2021-03-23 | IDEAYA Biosciences | Results IDEAYA Announces Dose Expansion in Phase 1/2 Study of IDE196 and Binimetinib Combination in Metastatic Uveal Melanoma Based on Early Clinical Activity ideayabio.com ↗
The IDE196 and binimetinib combination initiated dose expansion based on early clinical activity, including percentage of patients with tumor reduction. |
| 2019-09-29 | Pfizer | Results Pfizer Presents Interim Analysis Results from Phase 3 BEACON CRC Trial of BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer pfizer.com ↗
The BRAFTOVI Triplet also demonstrated a significantly improved ORR of 26% (95% CI: 18%, 35%) compared to 2% (95% CI: 0%, 7%) for Control (p<0.0001). |
All press releases naming this drug 16 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 135 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Binimetinib | “Phase Ib/II Study of the Efficacy and Safety of Binimetinib (MEK162) Plus Panitumumab for Mutant or Wild-Type RAS Metastatic Colorectal Cancer.” PMID 37597246 ↗ Dec 202396“The purpose of this study was to evaluate binimetinib, a potent MEK1/2 inhibitor with demonstrated activity across multiple cancers, in LGSOC.” PMID 32822286 ↗ Aug 2020 “Approved BRAF-/MEK- inhibitor combinations include dabrafenib/trametinib and encorafenib/binimetinib.” NCT05370807 ↗ “Encorafenib and binimetinib delivered to UK standard of care.” NCT06470880 ↗ “Binimetinib: 45 mg (3 × 15 mg oral tablet) twice daily (BID)” NCT06207656 ↗ “Binimetinib 45 mg 2 times a day daily orally” NCT06229340 ↗ “Drug: Binimetinib” NCT03563729 ↗ “Binimetinib” NCT05615818 ↗ |
| Known as | ARRY-162 | “An Open-Label, Phase I/II Study of Nilotinib (Tasigna) and MEK-162 (ARRY-162) Used in Combination” NCT02225574 ↗ |
| Known as | ARRY-438162 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00959127 ↗ |
| Known as | BIN | “Here, we present phase I safety results from an open-label, phase I/II study of pembrolizumab (PEM), encorafenib (ENC) and binimetinib (BIN) triplet therapy in advanced, B-Raf...” PMID 34655839 ↗ Oct 20211“binimetinib (BIN)” NCT04657991 ↗ |
| Known as | Bini | “The BEACON CRC study demonstrated that encorafenib (Enco)+cetuximab (Cetux)±binimetinib (Bini) significantly improved overall survival (OS) versus” PMID 39313594 ↗ Sep 2024 |
| Known as | MEK162 | “Binimetinib (also known as MEK162) is an orally bioavailable, selective and potent mitogenactivated protein (MAP) kinase (MEK1 and MEK2) inhibitor, which is approved for use in...” NCT04322383 ↗35“Phase Ib/II Study of the Efficacy and Safety of Binimetinib (MEK162) Plus Panitumumab for Mutant or Wild-Type RAS Metastatic Colorectal Cancer.” PMID 37597246 ↗ Dec 2023 “MEK162 is not FDA approved or commercially available.” NCT02089230 ↗ “ARRY-438162 (MEK162), MEK inhibitor; oral” NCT00959127 ↗ |
| Known as | MEK162/ARRY-438162 | “Binimetinib (MEK162/ARRY-438162) is an orally bioavailable, small molecule selective and potent mitogen-activated protein kinase (MEK) 1 and MEK 2 inhibitor.” NCT03475004 ↗ |
| Known as | MEKTOVI | “The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration.” NCT05103891 ↗ |
| Known as | NVP-MEK162 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3187723 ↗ |
| Action | Inhibit | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL3187723 ↗2“Dual specificity mitogen-activated protein kinase kinase 1 inhibitor” CHEMBL3187723 ↗ “MEK inhibitor” NCT00650767 ↗ |
| Modality | Small molecule | “MEK162, a small-molecule MEK1/2 inhibitor” PMID 23414587 ↗ Feb 2013 |
| Route | Oral | “ARRY-438162, MEK inhibitor; oral” NCT00650767 ↗ |
| Target | MAP2K1 | “Dual specificity mitogen-activated protein kinase kinase 1 inhibitor” CHEMBL3187723 ↗ |
| Target | MAP2K2 | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL3187723 ↗ |