HRP20230315T1 - Režim liječenja raka dojke korištenjem neratiniba - Google Patents

Režim liječenja raka dojke korištenjem neratiniba Download PDF

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Publication number
HRP20230315T1
HRP20230315T1 HRP20230315TT HRP20230315T HRP20230315T1 HR P20230315 T1 HRP20230315 T1 HR P20230315T1 HR P20230315T T HRP20230315T T HR P20230315TT HR P20230315 T HRP20230315 T HR P20230315T HR P20230315 T1 HRP20230315 T1 HR P20230315T1
Authority
HR
Croatia
Prior art keywords
neratinib
pharmaceutically acceptable
acceptable salt
hydrate
use according
Prior art date
Application number
HRP20230315TT
Other languages
English (en)
Inventor
Anna Berkenblit
Florence Binlich
Paul Goss
Original Assignee
Wyeth Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42313339&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20230315(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Wyeth Llc filed Critical Wyeth Llc
Publication of HRP20230315T1 publication Critical patent/HRP20230315T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4709Non-condensed quinolines and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/47064-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mycology (AREA)
  • Biomedical Technology (AREA)
  • Oncology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (10)

1. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu u postupku za liječenje HER-2/neu prekomjerno izraženog/pojačanog raka dojke u produženom režimu adjuvanta neratiniba, naznačen time što postupak sadrži isporuku produženog režima adjuvanta neratiniba pacijentici s HER-2/neu prekomjerno izraženim/pojačanim rakom dojke, pri čemu se produženi režim adjuvanta neratiniba započinje najmanje 2 tjedna, najmanje jedan mjesec, najmanje šest mjeseci ili najmanje devet mjeseci nakon završetka terapije adjuvant trastuzumabom, i pri čemu se produženi režim adjuvanta neratiniba primjenjuje tijekom razdoblja od najmanje šest mjeseci, najmanje 12 mjeseci, najmanje 18 mjeseci, 8 mjeseci do 5 godina ili 12 mjeseci do tri godine.
2. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema zahtjevu 1, naznačen time što produženi režim adjuvanta neratiniba smanjuje stopu recidiva HER-2/neu prekomjerno izraženog/pojačanog raka dojke kod pacijenta.
3. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema zahtjevu 1 ili 2, naznačen time što produženi režim adjuvanta neratiniba poboljšava invazivno preživljenje bez bolesti (IDFS), preživljenje bez bolesti - duktalni karcinom in situ (DFS-DCIS), udaljeno preživljenje bez bolesti (DDFS) i/ili vrijeme do udaljenog recidiva (TTDR) kod pacijenta.
4. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema bilo kojem od zahtjeva 1 do 3, naznačen time što je neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat u obliku jedinične doze.
5. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema zahtjevu 4, naznačen time što jedinični dozni oblik sadrži od 0.1 do 300 mg ili od 2 do 100 mg neratiniba ili njegove farmaceutski prihvatljive soli ili hidrata.
6. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema zahtjevu 4 ili 5, naznačen time što je jedinični dozni oblik tableta, kapsula ili prašak u vrećicama ili bočicama.
7. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema bilo kojem od zahtjeva 4 do 6, naznačen time što se neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat oralno primjenjuje od 1 do 6 puta na dan.
8. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema zahtjevu 7, naznačen time što se neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat oralno primjenjuje od 1 do 4 puta dnevno.
9. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema bilo kojem od zahtjeva 4 do 8, naznačen time što se neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat primjenjuje u dozi od 120 mg do 300 mg dnevno, ili 240 mg dnevno.
10. Neratinib ili njegova farmaceutski prihvatljiva sol ili hidrat za uporabu prema bilo kojem od zahtjeva 1 do 9, naznačen time što je farmaceutski prihvatljiva sol sulfat, citrat, acetat, oksalat, klorid, bromid, jodid, nitrat, bisulfat, fosfat, kiseli fosfat, izonikotinat, laktat, salicilat, kiselinski citrat, tartrat, oleat, tanat, pantotenat, bitartrat, askorbat, sukcinat, maleat, gentizinat, fumarat, glukonat, glukaronat, saharat, format, benzoat, glutamat, metan sulfonat, etansulfonat, benzensulfonat, p-toluensulfonat, 1,1'-metilen-bis-(2-hidroksi-3-naftoat), kaproat, laurat, miristat, palmitat, stearat, oleat, linoleat, ili linolenat sol.
HRP20230315TT 2009-04-06 2010-03-24 Režim liječenja raka dojke korištenjem neratiniba HRP20230315T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16679609P 2009-04-06 2009-04-06
EP15188350.1A EP3000467B1 (en) 2009-04-06 2010-03-24 Treatment regimen utilizing neratinib for breast cancer

Publications (1)

Publication Number Publication Date
HRP20230315T1 true HRP20230315T1 (hr) 2023-05-12

Family

ID=42313339

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20230315TT HRP20230315T1 (hr) 2009-04-06 2010-03-24 Režim liječenja raka dojke korištenjem neratiniba

Country Status (31)

Country Link
US (1) US9211291B2 (hr)
EP (3) EP2416774B1 (hr)
JP (7) JP5992325B2 (hr)
KR (6) KR20190128004A (hr)
CN (3) CN102369010A (hr)
AR (1) AR076197A1 (hr)
AU (1) AU2010234968B2 (hr)
BR (1) BRPI1012699A2 (hr)
CA (1) CA2755789C (hr)
CY (2) CY1125948T1 (hr)
DK (1) DK3000467T3 (hr)
ES (2) ES2941894T3 (hr)
FI (2) FI3000467T3 (hr)
FR (1) FR23C1027I1 (hr)
HK (2) HK1167313A1 (hr)
HR (1) HRP20230315T1 (hr)
HU (2) HUE061640T2 (hr)
IL (4) IL305394A (hr)
LT (2) LT3000467T (hr)
MX (1) MX356593B (hr)
NL (1) NL301237I2 (hr)
NO (1) NO2023028I1 (hr)
NZ (1) NZ595143A (hr)
PL (1) PL3000467T3 (hr)
PT (1) PT3000467T (hr)
RU (2) RU2011139363A (hr)
SG (1) SG174382A1 (hr)
SI (1) SI3000467T1 (hr)
TW (2) TWI557108B (hr)
WO (1) WO2010117633A1 (hr)
ZA (1) ZA201108118B (hr)

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CN109464445A (zh) 2008-08-04 2019-03-15 惠氏有限责任公司 4-苯胺基-3-氰基喹啉和卡培他滨的抗肿瘤组合
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