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An HDAC inhibitor for relapsed myeloma approved in 2015 and withdrawn in 2021 after its confirmatory trial was never completed.
Panobinostat is a pan-HDAC inhibitor that blocks class I, II and IV histone deacetylases including HDAC6. Inhibiting HDAC6 disrupts aggresome-mediated disposal of misfolded proteins, which synergises with proteasome inhibition in myeloma. PANORAMA-1 showed median progression-free survival of 12 versus 8.1 months when panobinostat was added to bortezomib-dexamethasone, at the cost of severe diarrhoea and cardiac events. The FDA granted accelerated approval in 2015 restricted to patients after at least two regimens including bortezomib and an immunomodulatory drug, and the EU approved it the same year. The confirmatory trial was never completed, and Secura Bio withdrew the US approval in 2021. Panobinostat showed that HDAC inhibition adds real activity in myeloma, but its toxicity meant the trade-off never earned a permanent place.
Inhibits class I, II and IV HDACs including HDAC6, disrupting aggresome-mediated protein disposal and synergising with proteasome inhibition in myeloma.
1.Panobinostat slips into a pocket on its target.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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In combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior regimens, including BTZ and an immunomodulatory agent.
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
In combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior regimens, including BTZ and an immunomodulatory agent.
Withdrawn: the indication came off the label 7.1 years after its accelerated approval.
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Multiple myeloma after ≥2 regimens including bortezomib and an IMiD · Withdrawn 2021 |
| EU | 2015 | Relapsed/refractory multiple myeloma |
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Query for this drug: (TITLE:"Panobinostat" OR ABSTRACT:"Panobinostat" OR TITLE:"Farydak" OR ABSTRACT:"Farydak") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Panobinostat, not a curated reading list.
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Multiple myeloma.
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Novartis.
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).