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]

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This year’s annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago came to an end yesterday.

The fourth day of the meeting, which was Monday, was the busiest day in regard to myeloma-related re­search. It started with an oral pre­sen­ta­tion session that in­cluded seven talks about im­por­tant new myeloma-related re­search. A poster session in the afternoon in­cluded several posters about myeloma-related re­search.

This article summarizes the most im­por­tant findings from Monday’s oral pre­sen­ta­tion session. A later article will cover the findings from the after­noon poster session.

The morning session …

- 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 …