ME02492B - Lapatanib za lečenje kancera - Google Patents

Lapatanib za lečenje kancera

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Publication number
ME02492B
ME02492B MEP-2016-168A MEP16816A ME02492B ME 02492 B ME02492 B ME 02492B ME P16816 A MEP16816 A ME P16816A ME 02492 B ME02492 B ME 02492B
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ME
Montenegro
Prior art keywords
hla
lapatinib
pharmaceutically acceptable
acceptable salt
pharmaceutical composition
Prior art date
Application number
MEP-2016-168A
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German (de)
English (en)
French (fr)
Inventor
Nan Bing
Linda Perry Briley
Laura R Budde
Charles J Cox
Colin F Spraggs
Original Assignee
Novartis Ag
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43607603&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME02492(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of ME02492B publication Critical patent/ME02492B/me

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    • AHUMAN NECESSITIES
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    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • 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
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41961,2,4-Triazoles
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed 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
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
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    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C12Q1/6886Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
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    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • GPHYSICS
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Claims (15)

1.Lapatinib, ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, za upotrebu u lečenju kancera kod čoveka, naznačen time, što je za pomenutog ispitanika utvrđeno da nije nosilac jednog ili više alelnih polimorfizama izabranih iz grupe koju čine: HLA-DQA1*0201, HLA-DQB1*0202, i/ili HLA-DRB1*0701.
2.Lapatinib, ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, za upotrebu u lečenju kancera kod čoveka prema patentnom zahtevu 1, naznačen time što je za pomenutog ispitanika utvrđeno da nije nosilac najmanje dva polimorfizma izabrana iz grupe koju čine: HLA-DRB1*0701, HLA-DQA1*0201, i/ili HLA-DQB1*0202.
3.Lapatinib, ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, za upotrebu u lečenju kancera kod čoveka prema patentnom zahtevu 1 ili patentnom zahtevu 2, naznačen time, što se pomenuti lapatinib ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, primenjuje zajedno sa najmanje još jednim antikancerskim agensom.
4.Lapatinib, ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, za upotrebu u lečenju kancera kod čoveka prema patentnom zahtevu 3, naznačen time, što je pomenuti, najmanje jedan, dodatni antikancerski agens izabran iz grupe koju čine: trastuzumab, kapecitabin, paklitaksel, karboplatin, pazopanib i letrozol.
5.Lapatinib, ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, za primenu kod tretirane populacije humanih ispitanika obolelih od kancera, naznačen time, što je pomenuta tretirana populacija izabrana iz početne populacije humanih ispitanika obolelih od kancera i što ima smanjeni procenat ispitanika koji su nosioci polimorfnog HLA alela izabranog iz grupe koju čine: HLA-DQA1*0201, HLA-DQB1*0202 i HLA-DRB1*0701 u poređenju sa početnom populacijom.
6.Lapatinib, ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, za upotrebu u lečenju čoveka obolelog od kancera prema bilo kojem od patentnih zahteva od 1 do 5, naznačen time što je za pomenutog ispitanika takođe utvrđeno da nije nosilac polimorfizama i/ili genotipova rs12153855 i/ili rs17207923 na TNXB genu.
7.Postupak ispitivanja (skrininga) humanog ispitanika obolelog od kancera kao pomoć u predviđanju pojave hepatotoksičnosti povezane sa lapatinibom ili njegovom farmaceutski prihvatljivom soli ili farmaceutskom kompozicijom, koji obuhvata određivanje da li ispitanik ima HLA genotip izabran iz grupe koju čine: HLA-DQA1*0201, HLA-DQB1*0202 i HLA-DRB1*0701, naznačen time što prisustvo takvog HLA genotipa ukazuje na povišen rizik od hepatotoksičnosti povezane sa lapatinibom ili njegovom farmaceutski prihvatljivom soli ili farmaceutskom kompozicijom kod pomenutog humanog ispitanika, u poređenju sa rizikom očekivanim kod opšte populacije.
8.Postupak prema patentnom zahtevu 7 dalje obuhvata utvrđivanje postojanja međusobne povezanosti otkrivanja HLA-DQA1*0201, HLA-DQB1*0202 i/ili HLA-DRB1*0701 alela i povišenog rizika od pojave hepatotoksičnosti povezane sa lapatinibom ili njegovom farmaceutski prihvatljivom soli ili farmaceutskom kompozicijom.
9.Postupak prema patentnom zahtevu 7 ili prema patentnom zahtevu 8, dalje obuhvata određivanje da li je pomenuti ispitanik nosilac genotipa HLA-B*4403, i/ili rs12153855 i/ili rs17207923 na TNXB genu.
10.Postupak prema bilo kojem od patentnih zahteva od 7 do 9 dalje obuhvata određivanje da li je pomenuti ispitanik DQ2.2. seropozitivan.
11.Postupak identifikacije humanog ispitanika obolelog od kancera kod koga postoji povišeni rizik od hepatotoksičnosti povezane sa terapijskim režimom primene lapatiniba, ili njegove farmaceutski prihvatljive soli ili farmaceutske kompozicije, obuhvata: a.izvođenje tehnike genotipizacije na biološkom uzorku poreklom od pomenutog ispitanika u cilju određivanja da li HLA genotip humanog ispitanika uključuje alel izabran iz grupe koju čine: HLA-DQA1*0201, HLA-DQB1*0202 ili HLA-DRB1*0701; b.detektovanje HLA-DQA1*0201, HLA-DQB1*0202 i/ili HLA-DRB1*0701; i c.utvrđivanje postojanja međusobne povezanosti otkrivanja HLA-DQA1*0201, HLA-DQB1*0202 i/ili HLA-DRB1*0701 alela i povećanog rizika od pojave hepatotoksičnosti povezane sa terapijskim režimom primene lapatiniba, ili njegove farmaceutski prihvatljive soli ili farmaceutske kompozicije, u poređenju sa rizikom u slučaju da nijedan od HLA-DQA1*0201, HLA-DQB1*0202 i/ili HLA-DRB1*0701 alela nije otkriven.
12.Postupak prema patentnom zahtevu 11 naznačen time što je pomenuti ispitanik nosilac oba, i HLA-DQA1*0201 i HLA-DQB1*0202 polimorfizma.
13. Postupak prema patentnom zahtevu 11 ili patentnom zahtevu 12, naznačen time, što dalje obuhvata izvođenje tehnike genotipizacije na biološkom uzorku poreklom od pomenutog ispitanika u cilju određivanja da li pomenuti ispitanik ima genotipove rs12153855 i/ili rs17207923 na TNXB genu i utvrđivanje postojanja međusobne povezanosti otkrivanja genotipova rs12153855 i/ili rs17207923 na TNXB genu i povišenog rizika od pojave hepatotoksičnosti povezane sa lapatinibom ili njegovom farmaceutski prihvatljivom soli ili farmaceutskom kompozicijom, u poređenju sa rizikom u slučaju da nijedan od genotipova rs12153855 i/ili rs17207923 na TNXB genu nije otkriven.
14.Lapatinib, ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, za upotrebu u lečenju kancera kod čoveka prema bilo kojem od patentnih zahteva od 1 do 6, ili postupak prema bilo kojem od patentnih zahteva od 11 do 13, naznačen time, što je utvrđeno da je pomenuti ispitanik DQ2.2. seropozitivan.
15. Lapatinib, ili njegova farmaceutski prihvatljiva so ili farmaceutska kompozicija, za upotrebu u lečenju čoveka obolelog od kancera prema bilo kojem od patentnih zahteva od 1 do 6 ili 14, ili postupak prema bilo kojem od patentnih zahteva od 7 do 13, naznačen time, što pomenuti kancer predstavlja kancer dojke.
MEP-2016-168A 2009-08-21 2010-08-20 Lapatanib za lečenje kancera ME02492B (me)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US23594709P 2009-08-21 2009-08-21
US30756910P 2010-02-24 2010-02-24
EP10810654.3A EP2467140B1 (en) 2009-08-21 2010-08-20 Lapatinib for treating cancer
PCT/US2010/046142 WO2011022633A2 (en) 2009-08-21 2010-08-20 Method of threating cancer

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US (3) US20120156200A1 (me)
EP (1) EP2467140B1 (me)
JP (1) JP5876827B2 (me)
KR (1) KR101781658B1 (me)
CN (1) CN102770140B (me)
AU (2) AU2010284092A1 (me)
BR (1) BR112012003653A2 (me)
CA (2) CA2771699C (me)
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