Novartis drug Farydak® recommended by CHMP for EU approval to treat multiple myeloma, providing patients a new mechanism of action

Novartis International AG / Novartis drug Farydak® recommended by CHMP for EU approval to treat multiple myeloma, providing patients a new mechanism of action . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Farydak (panobinostat) combination improved PFS by 7.8 months for patients who received >=2 prior regimens including bortezomib and an IMiD[1]

• Farydak would be the first HDAC inhibitor with epigenetic activity to treat multiple myeloma[2],[3]

• CHMP positive opinion marks a key milestone toward panobinostat availability in the EU, aligning with recent US FDA approval

Basel, June 26, 2015 - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Farydak® (panobinostat, previously known as LBH589) capsules, in combination with bortezomib[*] and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent (IMiD). If approved in the EU, panobinostat will be first in its class of anticancer agents available to these patients[1].

Multiple myeloma is a cancer of the plasma cells, a type of white blood cell present in the bone marrow, and affects approximately 84,000 people in Europe[4],[5]. Panobinostat is the first histone deacetylase (HDAC) inhibitor to show efficacy in multiple myeloma[2]. As an HDAC inhibitor, its epigenetic activity may help restore cell function in patients with multiple myeloma[3].

"Panobinostat is the first and only HDAC inhibitor recommended by the CHMP for the treatment of patients living with multiple myeloma who have progressed after standard-of-care therapy with bortezomib and an IMiD," said Alessandro Riva, MD, Global Head of Oncology Development and Medical Affairs, Novartis Oncology. "We are pleased with the positive CHMP opinion on panobinostat for previously treated patients because it brings us one step closer to providing a new treatment option for patients in need in Europe."