Title:
TREATMENT OF HEPATOCELLULAR CARCINOMA
Document Type and Number:
WIPO Patent Application WO/2018/212202
Kind Code:
A1
Abstract:
This disclosure provides methods for treating a hepatocellular carcinoma (e.g., unresectable HCC) with lenvatinib or a pharmaceutically acceptable salt thereof. Also encompassed by the disclosure are dosage regimens described herein of lenvatinib or a pharmaceutically acceptable salt thereof for use in treating hepatocellular carcinoma (e.g., unresectable hepatocellular carcinoma) according to any of the methods described herein. Particularly useful dosages and dose modifications upon the occurrence of an adverse event or events are also disclosed.
Inventors:
TAMAI TOSHIYUKI (JP)
Application Number:
PCT/JP2018/018810
Publication Date:
November 22, 2018
Filing Date:
May 15, 2018
Export Citation:
Assignee:
EISAI R&D MAN CO LTD (JP)
International Classes:
A61K31/47; A61P1/16; A61P35/00
Other References:
IKEDA, KENJI ET AL.: "Phase 2 study of lenvatinib in patients with advanced hepatocellular carcinoma", J. GASTROENTEROL., vol. 52, 4 October 2016 (2016-10-04), pages 512 - 519, XP036191714, [retrieved on 20180727]
IKEDA, MASAFUMI ET AL.: "Safety and pharmacokinetics of lenvatinib in patients with advanced hepatocellular carcinoma", CANCER RES., 23 October 2015 (2015-10-23), XP055549582, [retrieved on 20180727]
KUDO, MASATOSHI ET AL.: "Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial", LANCET, vol. 391, 9 February 2018 (2018-02-09), pages 1163 - 1173, XP085366785, [retrieved on 20180727]
ANONYMOUS: "Pharmaceuticals Interview Form ''LENVIMA", Ver.5", PMDA, March 2018 (2018-03-01), pages 1 - 97, XP009519178
"Pharmaceuticals Interview Form "LENVIMA", Ver.1,", PMDA, vol. Ver. 1, 26 March 2015 (2015-03-26), pages 1 - 61, XP009517195, Retrieved from the Internet
MIZUSHIMA, TORU: "Drug repositioning", BIO INDUSTRY, vol. 31, no. 11, 12 November 2014 (2014-11-12), pages 4 - 10, XP009517202, ISSN: 0910-6545
See also references of EP 3624800A4
IKEDA, MASAFUMI ET AL.: "Safety and pharmacokinetics of lenvatinib in patients with advanced hepatocellular carcinoma", CANCER RES., 23 October 2015 (2015-10-23), XP055549582, [retrieved on 20180727]
KUDO, MASATOSHI ET AL.: "Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial", LANCET, vol. 391, 9 February 2018 (2018-02-09), pages 1163 - 1173, XP085366785, [retrieved on 20180727]
ANONYMOUS: "Pharmaceuticals Interview Form ''LENVIMA", Ver.5", PMDA, March 2018 (2018-03-01), pages 1 - 97, XP009519178
"Pharmaceuticals Interview Form "LENVIMA", Ver.1,", PMDA, vol. Ver. 1, 26 March 2015 (2015-03-26), pages 1 - 61, XP009517195, Retrieved from the Internet
MIZUSHIMA, TORU: "Drug repositioning", BIO INDUSTRY, vol. 31, no. 11, 12 November 2014 (2014-11-12), pages 4 - 10, XP009517202, ISSN: 0910-6545
See also references of EP 3624800A4
Attorney, Agent or Firm:
HASEGAWA Yoshiki et al. (JP)
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