Delving into the Latest Updates on Fotemustine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(+-)-Diethyl (1-(3-(2-chloroethyl)-3-nitrosoureido)ethyl)phosphonate, Diethyl-1-(3-(2-chloroethyl)-3-nitrosoureido)ethylphosphonate, Fotemustine (INN/BAN)

+ [8]

Target

DNA

Mechanism

DNA inhibitors(DNA inhibitors), DNA alkylating agents

Therapeutic Areas

NeoplasmsNervous System DiseasesSkin and Musculoskeletal Diseases

Active Indication

MelanomaBrain Cancer

Inactive Indication

Non-Small Cell Lung CancerUveal Melanoma

Originator Organization-

Active Organization

Les Laboratoires Servier SAS

Inactive Organization

Servier Pharmaceuticals LLCStartup

Drug Highest PhaseApproved

First Approval Date

NZ (11 Dec 1991),

Melanoma

Regulation-

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Structure/Sequence

Molecular FormulaC9H19ClN3O5P

InChIKeyYAKWPXVTIGTRJH-UHFFFAOYSA-N

CAS Registry92118-27-9

The purpose of this study is to evaluate the activity of Vemurafenib in combination with Fotemustine in Patients with unresectable Stage IV melanoma harboring V600 BRAF mutation who recurred while in treatment with Vemurafenib. In addition the feasibility and safety profile of prolonging treatment of this drugs combination will be assessed.

Start Date01 Feb 2013

Sponsor / Collaborator

Istituto Nazionale Dei Tumori

EUCTR2012-004301-27-IT

/ Not yet recruitingPhase 3IIT

A randomized, Phase III study of Fotemustine versus the Combination of Fotemustine and Ipilimumab in Patients with Metastatic Melanoma with brain metastasis - NIBIT-M2

Start Date08 Nov 2012

Sponsor / Collaborator-

100 Clinical Results associated with Fotemustine

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100 Translational Medicine associated with Fotemustine

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100 Patents (Medical) associated with Fotemustine

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590

Literatures (Medical) associated with Fotemustine

01 Nov 2024·Pigment Cell & Melanoma Research

Detection of cell‐free tumor DNA in cerebrospinal fluid as a diagnostic biomarker for leptomeningeal melanoma metastasis: A case series

Article

Author: Vounckx, Manon ; Neyns, Bart ; Lauwyck, Justine ; Awada, Gil ; Kessels, Jolien I. ; Dirven, Iris ; Vanbinst, Anne‐Marie

Abstract:

Leptomeningeal melanoma metastases (LMM) are associated with poor survival. Diagnosis is based on clinical presentation, brain MRI and cerebrospinal fluid (CSF) analysis. Inconclusive findings at initial presentation can delay treatment. In this single‐center case series, detection of BRAFV600‐ and NRASQ61‐mutant cell‐free tumor DNA (cfDNA) in CSF was evaluated as a complementary diagnostic biomarker. In 12 patients with clinical suspicion of LMM, a retrospective analysis of MRI, CSF cytology and cfDNA analysis on 1 mL of CSF using the Idylla® platform was carried out. Nine patients displayed MRI abnormalities suggesting LMM. CSF analysis identified malignant cells in three patients (including one without MRI abnormalities). BRAFV600‐ or NRASQ61‐mutant cfDNA was detected in CSF of nine patients (eight with and one without MRI abnormalities; all patients with positive CSF cytology). Subsequent follow‐up confirmed LMM in all patients with positive and in one patient with a negative CSF cfDNA analysis (sensitivity 81.8%; specificity 100%). Our findings suggest that analyzing BRAFV600‐ and NRASQ61‐mutant cfDNA in CSF using the Idylla® platform holds promise as a sensitive and specific complementary diagnostic biomarker for LMM, particularly in case of inconsistency between imaging and CSF cytology. The 110‐min analysis can facilitate urgent treatment decisions.

01 Jul 2024·JOURNAL OF NEURO-ONCOLOGY

Long term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240)

Article

Author: Reyns, Nicolas ; Bonneterre, Marie-Edith ; Vannod-Michel, Quentin ; Vauleon, Enora ; Peciu-Florianu, Iulia

Abstract:

Purpose:

Glioblastoma remains incurable despite optimal multimodal management. The interim analysis of open label, single arm INDYGO pilot trial showed actuarial 12-months progression-free survival (PFS) of 60% (median 17.1 months), actuarial 12-months overall survival (OS) of 80% (median 23.1 months). We report updated, exploratory analyses of OS, PFS, and health-related quality of life (HRQOL) for patients receiving intraoperative photodynamic therapy (PDT) with 5-aminolevulinic acid hydrochloride (5-ALA HCl).

Methods:

Ten patients were included (May 2017 – April 2021) for standardized therapeutic approach including 5-ALA HCl fluorescence-guided surgery (FGS), followed by intraoperative PDT with a single 200 J/cm2 dose of light. Postoperatively, patients received adjuvant therapy (Stupp protocol) then followed every 3 months (clinical and cerebral MRI) and until disease progression and/or death. Procedure safety and toxicity occurring during the first four weeks after PDT were assessed. Data concerning relapse, HRQOL and survival were prospectively collected and analyzed.

Results:

At the cut-off date (i.e., November 1st 2023), median follow-up was 23 months (9,7–71,4). No unacceptable or unexpected toxicities and no treatment-related deaths occurred during the study. Kaplan–Meier estimated 23.4 months median OS, actuarial 12-month PFS rate 60%, actuarial 12-month, 24-month, and 5-year OS rates 80%, 50% and 40%, respectively. Four patients were still alive (1 patient free of recurrence).

Conclusion:

At 5 years-follow-up, intraoperative PDT with surgical maximal excision as initial therapy and standard adjuvant treatment suggests an increase of time to recurrence and overall survival in a high proportion of patients. Quality of life was maintained without any severe side effects.

Trial registration NCT number:

NCT03048240. EudraCT number: 2016–002706-39.

01 Jun 2024·MARINE POLLUTION BULLETIN

Predicted concentrations of antineoplastic drugs in the aquatic environment: The case of Ría de Vigo (NW, Spain)

Article

Author: Couñago-Fernández, Moisés ; Otero, Pablo ; Muniategui-Lorenzo, Soledad ; Paradela-Carreiro, Adolfo ; Samartín-Ucha, Marisol ; Martínez-López de Castro, Noemí

The European Medicines Agency (EMA) mandates Environmental Risk Assessments (ERAs) since 2006 to determine potential risks of new marketed medicines. Drugs with a Predicted Environmental Concentration (PEC) in inland surface waters exceeding 0.01 μg L^-1 require further environmental risk assessment. PEC may be refined based on prevalence data and/or based on the treatment regimen. In this study, based on EMA regulations, refined PEC of 108 antineoplastic drugs in coastal waters were determined based on the consumption in a coastal health area during 2021, identifying six drugs with potential environmental risk in surface waters (hydroxyurea, capecitabine, abiraterone, ibrutinib, imatinib and 5-fluorouracil) and two in marine ecosystem (hydroxyurea and capecitabine). Comparison of these refined PECs with data from marketing laboratories revealed significant disparities, suggesting the need for regular updates, especially with changes in drug indications or financing. Notably, the identified drugs are not yet on the main reference lists of emerging contaminants.

100 Deals associated with Fotemustine

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External Link

KEGG	Wiki	ATC	Drug Bank
D07255	Fotemustine	L01AD05	DB04106

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Melanoma	NZ	-	11 Dec 1991
Brain Cancer	CN	Les Laboratoires Servier SAS	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Uveal Melanoma	Phase 3	FR	Servier Pharmaceuticals LLCStartup	23 Jun 2009
Uveal Melanoma	Phase 3	CH	Servier Pharmaceuticals LLCStartup	23 Jun 2009
Non-Small Cell Lung Cancer	Phase 2	FR	-	-
Non-Small Cell Lung Cancer	Phase 2	GB	-	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2022	Not Applicable	Recurrent Glioblastoma	42	Fotemustine and Bevacizumab	khfzxzjqgh(vnqhdpufhv) = An increase in hematologic adverse events stands out in our pts fluphnavmu (wonokjumxq )	-	02 Jun 2022
NCT02460068 (NIBIT-M2, ESMO2020) Manual	Phase 3	Metastatic melanoma First line	76	fotemustine	adfvofdkpv(sesvalzpyv) = pgsuylpept syqppqnvbk (zbpfwhkhfu, 4.8 - 12.2) View more	Positive	18 Sep 2020
				ipilimumab+fotemustine	adfvofdkpv(sesvalzpyv) = fmgizsyliy syqppqnvbk (zbpfwhkhfu, 2.0 - 14.3) View more
NCT01960192 (Pubmed \| J Neurooncol) Manual	Phase 2	Primary Central Nervous System Lymphoma BCL6 Overexpression	49	Fotemustine+teniposide+dexamethasone	nhzuehnpfj(wbgkbivwvj) = usymdlcrcy moleeoonxo (oyxtvxqerb ) View more	Positive	01 Nov 2018
				methotrexate+cytarabine	nhzuehnpfj(wbgkbivwvj) = nrsnixjzlf moleeoonxo (oyxtvxqerb ) View more
NCT02843386 (ASCO 12017 \| ASCO 22017) Manual	Phase 3	Uveal Melanoma Adjuvant	244	fotemustine	uewpqkeete(zkytufkfss) = hntlvjjccp dgdtnvqsiu (hffehfgdcb ) View more	Negative	04 Jun 2017
				surveillance	uewpqkeete(zkytufkfss) = jwpccclqwn dgdtnvqsiu (hffehfgdcb )
NCT01983124 (Pubmed) Manual	Phase 2	BRAF V600 mutation-positive Melanoma BRAF V600 Mutation	31	vemurafenib+fotemustine	dekpkkccqs(ddipkqkekt) = bgurzaklag jevckbuiit (otghefuaam ) View more	Positive	13 Jul 2016
NCT01474239 (AVAREG (ML25739), ASCO2015)	Phase 2	Recurrent Glioblastoma	91	Bevacizumab	hcsuihouuf(zfkkzxekwg) = ujexwvmvkl avkyvfhbeu (ztcgxxizou, 48.4 - 74.5) View more	-	20 May 2015
				Fotemustine	hcsuihouuf(zfkkzxekwg) = fwiuwbtwjh avkyvfhbeu (ztcgxxizou, 54.1 - 87.7) View more
GLIOSTRY (ASCO2015)	Not Applicable	Glioblastoma	921	Fotemustine	gotooecgqm(jkhsbcnhjj) = mbkywmhhgu pwublbhesd (bogsilzlmq ) View more	-	20 May 2015
EUCTR2011-001363-46-IT (AVAREG-ML25739, SNO2014)	Phase 2	Glioblastoma Multiforme	91	Bevacizumab 10 mg/m2	xldforgqzm(bqrnkpolkt) = dabcprqexp ensqlazkml (dodpckyguh, 48.4 - 74.5) View more	Positive	01 Nov 2014
				Fotemustine 75 mg/m2	xldforgqzm(bqrnkpolkt) = ebluwfelno ensqlazkml (dodpckyguh, 54.1 - 87.7) View more
GEINOFOTE (ASCO2014)	Not Applicable	High grade glioma	114	fotemustine (FT) (Addeo schedule)	fdonzzuxob(wercqhbrft) = uqzdjfclyf xntyzidjof (wdwfuqqdds ) View more	-	20 May 2014
				fotemustine (FT) (Others schedule)	fdonzzuxob(wercqhbrft) = baucseowys xntyzidjof (wdwfuqqdds ) View more
ASCO2014	Not Applicable	Melanoma	41	Fotemustine	qxgjzypdgh(rfpenladnz) = ½ Gr (23.1%) ciezdochxt (zlollxyoev ) View more	-	20 May 2014