FDA approves new agent for multiple myeloma

MP Fenichel - 2015 - academic.oup.com
MP Fenichel
2015academic.oup.com
In February, the US Food and Drug Administration (FDA) approved a new drug,
panobinostat, for multiple myeloma. A histone deacetylase (HDAC) inhibitor, panobinostat is
for patients who have relapsed and no longer respond to one of the most effective
treatments for multiple myeloma: the proteasome inhibitor bortezomib. Although
panobinostat is the first FDA-approved HDAC inhibitor for this disease, the approval comes
with a caveat. Under accelerated approval—which gives patients faster access to promising …
In February, the US Food and Drug Administration (FDA) approved a new drug, panobinostat, for multiple myeloma. A histone deacetylase (HDAC) inhibitor, panobinostat is for patients who have relapsed and no longer respond to one of the most effective treatments for multiple myeloma: the proteasome inhibitor bortezomib. Although panobinostat is the first FDA-approved HDAC inhibitor for this disease, the approval comes with a caveat. Under accelerated approval—which gives patients faster access to promising new drugs—no trials to confirm their clinical benefit more robustly have yet been completed. Novartis, the manufacturer, must conduct those trials. As the drug makes its way to market, some clinicians express concerns about its toxic side effects, which could outweigh the benefits. Nonetheless, many experts expect that these challenges will be overcome and that panobinostat will prove effective for some patients.
Oxford University Press