• Farydak, an HDAC inhibitor with epigenetic activity, approved in combination for patients who received at least two prior regimens including bortezomib and IMiD[1]
• Farydak prolonged median PFS benefit when used with bortezomib and dexamethasone combination versus combination alone (from 6 to 11 months)[1]
• Multiple myeloma is an incurable blood cancer and there is an urgent need for new treatments[2]
• Farydak is approved under FDA's accelerated approval program; regulatory applications are underway in the EU, Japan

 …

Silver Spring, MD (Press Release) - The U.S. Food and Drug Admin­istra­tion today approved Farydak (panobinostat) for the treat­ment of patients with multiple myeloma.

Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. According to the National Cancer Institute, approx­i­mately 21,700 Americans are diag­nosed with multiple myeloma and 10,710 die from the disease annually.

Primarily affecting older adults, multiple myeloma causes plasma cells to rapidly multiply and crowd out other healthy blood cells from the bone marrow. When …

Basel, Switzerland (Press Release) - Novartis announced today that the US Food and Drug Admin­istra­tion (FDA) has extended their priority review period by up to three months for the new drug appli­ca­tion (NDA) of LBH589 (panobinostat) in com­bi­na­tion with bor­tez­o­mib* and dexa­meth­a­sone for patients with pre­vi­ously treated multiple myeloma.

 …

• Results show statistically significant and clinically relevant increase in median progression-free survival with LBH589 plus bortezomib and dexamethasone[1]
• LBH589, a first-in-class treatment for patients with relapsed/refractory multiple myeloma if approved, helps extend benefit of standard-of-care therapy[1]
• First Phase III study to demonstrate superiority of a three-drug over two-drug combination in this patient population[1]
• Multiple myeloma, the second most common blood cancer, is incurable; most patients will relapse or become refractory so new treatments are needed[2],[3]

 …

• Results show adding LBH589 to bortezomib and dexamethasone significantly improved PFS by 37%, meeting Phase III study primary endpoint[1]
• Median PFS increased by 4 months (12 months in LBH589 arm versus 8 months in placebo arm); effect of LBH589 observed across all patient subgroups[1]
• Most people with multiple myeloma will relapse or become refractory; if approved, LBH589 will be first in its class of anticancer agents available to this population[1]
• Based on these data, US

 …

- Additional Preclinical Data Presented on Ricolinostat in Potential New Drug Combinations and HDAC6 Biomarkers in Multiple Myeloma -

Boston, MA (Press Release) - Acetylon Pharma­ceu­ticals, Inc., the leader in the devel­op­ment of selective histone deacetylase (HDAC) inhibitors for en­hanced thera­peutic out­comes, today announced that positive interim clin­i­cal data from the two proof-of-concept clin­i­cal trials with selective HDAC6 inhibitor, ricolinostat (ACY-1215), were presented at the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA. The two trials are the Phase 1b dose escalation portion of …

- Study of LBH589 plus bor­tez­o­mib and dexa­meth­a­sone met pri­mary end­point of extending PFS compared to bor­tez­o­mib plus dexa­meth­a­sone and placebo
- LBH589 has poten­tial to be the first in its class of anticancer agents avail­able to patients with multiple myeloma
- Data will be presented at an upcoming medical congress and discussed with regu­la­tory author­i­ties world­wide

Basel, Switzerland (Press Release) - Novartis today announced that results of a Phase III trial of the in­ves­ti­ga­tional com­­pound LBH589 (panobinostat) in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, met the pri­mary end­point of sig­nif­i­cantly extending pro­gres­sion-free …