IN THE PIPELINE
Recently Approved Agents
In 2015, the U.S. Food and Drug Administration approved
two agents for the treatment of patients with multiple
myeloma (MM): the HDAC inhibitor panobinostat and the
selective proteasome inhibitor carfilzomib.
Panobinostat: On February 23, 2015, the U.S. FDA approved
panobinostat for the treatment of patients with MM, making
it the first histone deacetylase (HDAC) inhibitor approved for
this condition. Panobinostat is indicated for patients who have
received at least two prior standard therapies – including bortezomib and an immunomodulatory agent – and is to be used
in combination with bortezomib and dexamethasone (PBD).
The safety and efficacy of the panobinostat combination was
demonstrated in a clinical trial of 193 patients with MM who
were randomly assigned to receive PBD or bortezomib + dexamethasone (BD) alone; treatment with panobinostat significantly
extended progression-free survival by four months. In addition,
59 percent of PBD-treated participants demonstrated response
after treatment, compared with only 41 percent in the BD group.
Panobinostat does carry a Boxed Warning about severe diarrhea
The Myeloma Pipeline
Below is a list of agents currently under investigation for
the treatment of multiple myeloma (MM), newly diagnosed
MM (NDMM), relapsed/refractory MM (RRMM), or smoldering MM. Information was gathered from ClinicalTrials.gov,
as well as the respective drug manufacturers.
MONOCLONAL ANTIBODIES
• Elotuzumab: anti-SLAMF7 monoclonal antibody for the treatment of patients with RRMM (phase III), NDMM (phase III), or
smoldering MM (phase II)
*For more about elotuzumab and the ELOQUENT-2 trial, see page 9
• Daratumumab: anti-CD38 monoclonal antibody for the frontline treatment of MM (phase III) or the treatment of patients
with RRMM (phase III)
*For more about daratumumab in patients with RRMM, see page 13
• SAR650984: anti-CD38 monoclonal antibody for the treatment
of patients with MM (phase II)
ANTIBODY DRUG CONJUGATES
• BT062 (indatuximab ravtansine): antibody drug conjugate
comprising an anti-CD138 monoclonal antibody (indatuximab)
and the cytotoxic agent ravtansine for the treatment of patients with RRMM (phase I/II)
PROTEASOME INHIBITORS
• Ixazomib: oral 20S proteasome inhibitor for patients with
RRMM (phase III)
6
Focus on Myeloma
and severe and fatal cardiac events, arrhythmias, and electrocardiogram changes that have occurred in patients receiving the
medication.
Carfilzomib: On July 24, 2015, the U.S. FDA approved carfilzomib in combination with lenalidomide and dexamethason