572 Oral panobinostat in patients with advanced tumors and impaired renal function: Relationship between pharmacokinetics and key safety parameters

Porro, Maria Grazia; Sharma, Sushil; Witteveen, P. O.; Lolkema, M.P.; Hess, Dagmar; Gelderblom, Hans; Hussain, Sana; Waldron, Edward; Valera, Sue-zette; Mu, Song

doi:10.1016/s0959-8049(14)70698-7

Cited by 1 publication

(1 citation statement)

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“…The effect of severe hepatic impairment on panobinostat pharmacokinetics has not been determined; therefore, panobinostat should not be administered in these patients. Mild to severe renal impairment did not impact plasma panobinostat exposure [6,22]; panobinostat has not been investigated in patients with end-stage renal disease or those undergoing dialysis [6].…”

Section: Pharmacokineticsmentioning

confidence: 99%

Panobinostat: First Global Approval

Garnock-Jones

2015

Drugs

169

109

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Novartis has developed oral and intravenous formulations of panobinostat (Farydak(®)), a histone deacetylase (HDAC) inhibitor, for the treatment of cancer. HDACs have important roles in maintaining chromatin structure and in regulating gene expression, including that of tumour suppressor genes, and thus represent valid targets in the search for cancer therapeutics. Oral panobinostat is approved in the US, as combination therapy with bortezomib and dexamethasone in patients with recurrent multiple myeloma who have received at least two prior treatment regimens, including bortezomib and an immunomodulatory agent. Regulatory submissions have been made for the use of combination therapy with panobinostat in patients with recurrent multiple myeloma in the EU and Japan. Panobinostat is in various stages of clinical development worldwide for a range of haematological and solid tumours. This article summarizes the milestones in the development of panobinostat leading to this first approval for multiple myeloma.

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Section: Pharmacokineticsmentioning

confidence: 99%