Farydak(panobinostat)

Oncology· 163 cited findings· 1 source document

Company: Secura Bio

What the regulatory reviews say

Farydak (panobinostat) received Accelerated Approval. In a clinical trial, the panobinostat + BD arm demonstrated a median progression-free survival (PFS) of 12.0 months (investigator-assessed) compared to 8.1 months in the placebo + BD arm. The PFS hazard ratio was 0.63 (95% CI: 0.52, 0.76) with a p-value of <0.0001. Discontinuation due to disease progression was 21% in the panobinostat arm versus 40% in the placebo arm. The Overall Response Rate (investigator-assessed) was 61% for panobinostat + BD and 55% for placebo + BD, with Complete Response rates of 11% and 6% respectively. The median duration of response in the panobinostat + BD arm was 13.1 months.

Safety findings indicated that 87% of patients experienced Grade 3/4 adverse events, and 73% had dose interruptions or modifications. Discontinuation due to adverse events occurred in 34% of patients in the panobinostat + BD arm, compared to 17% in the placebo + BD arm. 33% of patients were hospitalized due to adverse events. 99.7% of patients in the panobinostat arm experienced Grade 1-4 adverse events. The ODAC vote for benefit/risk was 2 Yes, 5 No, 0 Abstain. Farydak received orphan drug designation on August 20, 2012.

Key figures — cited to the source page

Median PFS (investigator-assessed) in panobinostat + BD arm	12.0	SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.7
Median PFS (investigator-assessed) in placebo + BD arm	8.1	SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.7
PFS hazard ratio (investigator-assessed)	0.63	SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.7
Discontinuation due to disease progression (panobinostat arm)	21	SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.7
Discontinuation due to disease progression (placebo arm)	40	SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.7
Discontinuation due to adverse events (panobinostat + BD arm)	34	SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.7
Patients with Grade 3/4 adverse events	87	SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.5
Regulatory action	Accelerated Approval	SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015), p.16

Source documents

SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015) (2015)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.