HRP20201632T1 - Režimi doziranja melflufena kod raka - Google Patents
Režimi doziranja melflufena kod raka Download PDFInfo
- Publication number
- HRP20201632T1 HRP20201632T1 HRP20201632TT HRP20201632T HRP20201632T1 HR P20201632 T1 HRP20201632 T1 HR P20201632T1 HR P20201632T T HRP20201632T T HR P20201632TT HR P20201632 T HRP20201632 T HR P20201632T HR P20201632 T1 HRP20201632 T1 HR P20201632T1
- Authority
- HR
- Croatia
- Prior art keywords
- melflufen
- dosage
- compound
- administered
- accordance
- Prior art date
Links
- YQZNKYXGZSVEHI-VXKWHMMOSA-N ethyl (2s)-2-[[(2s)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoyl]amino]-3-(4-fluorophenyl)propanoate Chemical compound C([C@@H](C(=O)OCC)NC(=O)[C@@H](N)CC=1C=CC(=CC=1)N(CCCl)CCCl)C1=CC=C(F)C=C1 YQZNKYXGZSVEHI-VXKWHMMOSA-N 0.000 title claims 12
- 206010028980 Neoplasm Diseases 0.000 title 1
- 201000011510 cancer Diseases 0.000 title 1
- 150000001875 compounds Chemical class 0.000 claims 14
- 150000003839 salts Chemical class 0.000 claims 6
- 239000003814 drug Substances 0.000 claims 5
- 208000034578 Multiple myelomas Diseases 0.000 claims 4
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 4
- 239000003186 pharmaceutical solution Substances 0.000 claims 4
- 229940079593 drug Drugs 0.000 claims 3
- 238000001802 infusion Methods 0.000 claims 3
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims 2
- 229960003957 dexamethasone Drugs 0.000 claims 2
- 229940124622 immune-modulator drug Drugs 0.000 claims 2
- 229960004942 lenalidomide Drugs 0.000 claims 2
- GOTYRUGSSMKFNF-UHFFFAOYSA-N lenalidomide Chemical compound C1C=2C(N)=CC=CC=2C(=O)N1C1CCC(=O)NC1=O GOTYRUGSSMKFNF-UHFFFAOYSA-N 0.000 claims 2
- 239000000137 peptide hydrolase inhibitor Substances 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 229940124158 Protease/peptidase inhibitor Drugs 0.000 claims 1
- 239000002168 alkylating agent Substances 0.000 claims 1
- 229960002204 daratumumab Drugs 0.000 claims 1
- 229940042399 direct acting antivirals protease inhibitors Drugs 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 229960000688 pomalidomide Drugs 0.000 claims 1
- UVSMNLNDYGZFPF-UHFFFAOYSA-N pomalidomide Chemical compound O=C1C=2C(N)=CC=CC=2C(=O)N1C1CCC(=O)NC1=O UVSMNLNDYGZFPF-UHFFFAOYSA-N 0.000 claims 1
- 238000011321 prophylaxis Methods 0.000 claims 1
- 238000011282 treatment Methods 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/223—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Emergency Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (15)
1. Melflufen, ili njegova sol, namijenjen upotrebi u liječenju ili profilaksi multiplog mijeloma, naznačen time što se doziranje melfulena od 35 do 45 mg, isključujući masu bilo koje soli, primjenjuje u obliku parenteralnog doziranja uz stopu infuzije od 1,2 do 1,4 mg/min.
2. Spoj namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time što je stopa infuzije 1,3 mg/min.
3. Spoj namijenjen upotrebi u skladu s patentnim zahtjevom 1 ili 2, naznačen time što se doziranje primjenjuje u trajanju od 25 do 35 minuta.
4. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što je doziranje melfulena, isključujući masu bilo koje soli, 37,5 do 42,5 mg, po mogućnosti 40 mg.
5. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što se doziranje melflufena primjenjuje u trajanju od otprilike 30 minuta.
6. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što se doziranje melflufena primjenjuje u obliku intravenske infuzije.
7. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što multipli mijelom recidivira, otporan je i/ili recidivira kao otporan multipli mijelom, primjerice kao otporan na u najmanju ruku na jedan lijek iz klase lijekova koje se bira između inhibitora proteaze, imunomodulacijskih lijekova ili alkilatora; primjerice kao otporan na najmanje jedan alkilator; i/ili, primjerice, kao otporan na u najmanju ruku na pomalidomid i/ili daratumumab.
8. Spoj namijenjen upotrebi u skladu s in bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što multipli mijelom recidivira i/ili recidivira kao u najmanju ruku otporan na lenalidomid; i osobitije na u najmanju ruku lenalidomid i 2, 3 ili 4 druga lijeka, uključujući najmanje jedan inhibitor proteaze i imunomodulacijski lijek.
9. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što se navedeni melflufen primjenjuje istodobno, uzastopno ili odvojeno od jednog ili više dodatnih terapijskih sredstava, primjerice gdje je navedeno dodatno terapijsko sredstvo deksametazon.
10. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što se doziranje melflufena primjenjuje u obliku farmaceutske otopine volumena od 200 do 500 ml, po mogućnosti 350 ml.
11. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što se doziranje melflufena primjenjuje u obliku farmaceutske otopine koja sadrži fiziološki prihvatljivu otopinu, primjerice otopinu glukoze.
12. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što se doziranje melflufena primijenjuje u obliku farmaceutske otopine, te što je koncentracija melflufena, ili njegove soli, u farmaceutskoj otopini 1,2 mg/ml ili manje, primjerice 0,2 do 1,2 mg/ml.
13. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačen time što se doziranje melflufena pripravlja iz liofiliziranog farmaceutskog pripravka koji sadrži melflufen, ili njegovu sol, te što može sadržavati sharozu.
14. Spoj namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što doziranje melflufena, ili njegova sol, se uzima 1. dana 21-dnevnog ciklusa ili ciklusa od 28 dana, te što se ciklus može ponavljati od 1 do 9 puta, po mogućnosti od 2 do 7 puta, primjerice 4 puta.
15. Spoj namijenjen upotrebi u skladu s patentnim zahtjevom 14, naznačen time što se deksametazon primjenjuje 1. dana u ciklusu; i također se može primijeniti 8. i 15. dana 21-dnevnog ciklusa, ili također se može primijeniti 8., 15. i 22. dana 28-dnevnog ciklusa.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1521217.8A GB201521217D0 (en) | 2015-12-01 | 2015-12-01 | Dosage regimens |
| EP16805792.5A EP3383385B2 (en) | 2015-12-01 | 2016-12-01 | Melflufen dosage regimens for cancer |
| PCT/EP2016/079511 WO2017093443A1 (en) | 2015-12-01 | 2016-12-01 | Melflufen dosage regimens for cancer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20201632T1 true HRP20201632T1 (hr) | 2021-01-08 |
| HRP20201632T4 HRP20201632T4 (hr) | 2023-11-10 |
Family
ID=55177548
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201632TT HRP20201632T4 (hr) | 2015-12-01 | 2016-12-01 | Režimi doziranja melflufena kod raka |
Country Status (27)
| Country | Link |
|---|---|
| US (2) | US20180369141A1 (hr) |
| EP (3) | EP3750534A1 (hr) |
| JP (2) | JP6878431B2 (hr) |
| KR (2) | KR20210092327A (hr) |
| CN (1) | CN108289876A (hr) |
| AU (2) | AU2016363591B2 (hr) |
| BR (1) | BR112018010012A8 (hr) |
| CA (1) | CA3003102C (hr) |
| CY (1) | CY1123469T1 (hr) |
| DK (1) | DK3383385T4 (hr) |
| ES (1) | ES2828033T5 (hr) |
| FI (1) | FI3383385T4 (hr) |
| GB (1) | GB201521217D0 (hr) |
| HR (1) | HRP20201632T4 (hr) |
| HU (1) | HUE051525T2 (hr) |
| IL (2) | IL301019A (hr) |
| LT (1) | LT3383385T (hr) |
| MX (2) | MX2018006706A (hr) |
| PL (1) | PL3383385T5 (hr) |
| PT (1) | PT3383385T (hr) |
| RS (1) | RS60986B2 (hr) |
| RU (2) | RU2020134307A (hr) |
| SG (1) | SG11201803551YA (hr) |
| SI (1) | SI3383385T2 (hr) |
| SM (1) | SMT202000567T1 (hr) |
| WO (1) | WO2017093443A1 (hr) |
| ZA (1) | ZA201802816B (hr) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2942468T3 (es) * | 2018-10-18 | 2023-06-01 | Oncopeptides Ab | Compuestos que contienen deuterio |
| AU2020215692A1 (en) * | 2019-01-28 | 2021-09-16 | Sanofi-Aventis U.S. Llc | Methods of treating multiple myeloma |
| EP3946309A1 (en) * | 2019-04-03 | 2022-02-09 | Oncopeptides AB | Treatment of al amyloidosis with melflufen |
| GB201905477D0 (en) * | 2019-04-17 | 2019-05-29 | Oncopeptides Ab | Novel formulations |
| WO2021053185A1 (en) * | 2019-09-20 | 2021-03-25 | Oncopeptides Ab | Melflufen formulations and their use in the treatment or prophylaxis of osteosarcoma |
| SE544998C2 (en) * | 2021-01-13 | 2023-02-21 | Bkmdcl Ab | Peptide conjugates of melphalan for the treatment of cancer |
| EP4366721A1 (en) * | 2021-07-08 | 2024-05-15 | Oncopeptides Innovation AB | Melflufen for use in the treatment of multiple myeloma |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE0002202D0 (sv) * | 2000-06-13 | 2000-06-13 | Karolinska Innovations Ab | New peptides |
| HUE060783T2 (hu) | 2011-04-28 | 2023-04-28 | Oncopeptides Ab | Citotoxikus dipeptidek liofilizált készítménye |
| US10042382B2 (en) | 2012-10-22 | 2018-08-07 | Parker Hannifin Manufacturing Sweden Ab | Joystick |
| CN108685860B (zh) * | 2012-10-26 | 2022-04-05 | 肿瘤多肽股份公司 | 美法仑氟灭酰胺的冻干制剂 |
| EP2983654A4 (en) * | 2013-04-08 | 2016-11-30 | Berg Llc | TREATMENT OF CANCER USING COENZYME POLYTHERAPIES Q10 |
-
2015
- 2015-12-01 GB GBGB1521217.8A patent/GB201521217D0/en not_active Ceased
-
2016
- 2016-12-01 KR KR1020217022171A patent/KR20210092327A/ko not_active Withdrawn
- 2016-12-01 RS RS20201289A patent/RS60986B2/sr unknown
- 2016-12-01 HU HUE16805792A patent/HUE051525T2/hu unknown
- 2016-12-01 EP EP20187064.9A patent/EP3750534A1/en not_active Withdrawn
- 2016-12-01 SI SI201630963T patent/SI3383385T2/sl unknown
- 2016-12-01 EP EP16805792.5A patent/EP3383385B2/en active Active
- 2016-12-01 WO PCT/EP2016/079511 patent/WO2017093443A1/en active Application Filing
- 2016-12-01 LT LTEP16805792.5T patent/LT3383385T/lt unknown
- 2016-12-01 HR HRP20201632TT patent/HRP20201632T4/hr unknown
- 2016-12-01 MX MX2018006706A patent/MX2018006706A/es unknown
- 2016-12-01 SG SG11201803551YA patent/SG11201803551YA/en unknown
- 2016-12-01 CA CA3003102A patent/CA3003102C/en active Active
- 2016-12-01 PL PL16805792.5T patent/PL3383385T5/pl unknown
- 2016-12-01 US US15/779,609 patent/US20180369141A1/en not_active Abandoned
- 2016-12-01 SM SM20200567T patent/SMT202000567T1/it unknown
- 2016-12-01 RU RU2020134307A patent/RU2020134307A/ru unknown
- 2016-12-01 FI FIEP16805792.5T patent/FI3383385T4/fi active
- 2016-12-01 PT PT168057925T patent/PT3383385T/pt unknown
- 2016-12-01 KR KR1020187014234A patent/KR102279629B1/ko active Active
- 2016-12-01 DK DK16805792.5T patent/DK3383385T4/da active
- 2016-12-01 AU AU2016363591A patent/AU2016363591B2/en active Active
- 2016-12-01 CN CN201680070133.3A patent/CN108289876A/zh active Pending
- 2016-12-01 BR BR112018010012A patent/BR112018010012A8/pt not_active Application Discontinuation
- 2016-12-01 IL IL301019A patent/IL301019A/en unknown
- 2016-12-01 ES ES16805792T patent/ES2828033T5/es active Active
- 2016-12-01 RU RU2018123718A patent/RU2734930C2/ru active
- 2016-12-01 JP JP2018528300A patent/JP6878431B2/ja active Active
- 2016-12-01 EP EP21179365.8A patent/EP3903777A1/en active Pending
-
2018
- 2018-04-26 ZA ZA2018/02816A patent/ZA201802816B/en unknown
- 2018-05-02 IL IL259101A patent/IL259101A/en unknown
- 2018-05-31 MX MX2021008738A patent/MX2021008738A/es unknown
-
2020
- 2020-10-21 CY CY20201100994T patent/CY1123469T1/el unknown
-
2021
- 2021-01-22 AU AU2021200436A patent/AU2021200436A1/en not_active Abandoned
- 2021-01-27 JP JP2021010894A patent/JP2021088560A/ja active Pending
- 2021-03-24 US US17/210,699 patent/US20220047507A1/en not_active Abandoned
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