The U.S. Food & Drug Administration (FDA) has expanded the approved indications for Actemra (tocilizumab) to include severe or life-threatening cytokine release syndrome (CRS), caused by CAR T-cell therapy.
The expanded approval came just months after an independent review of the FDA’s database linked Actemra to thousands of adverse events, including over 1,000 deaths.
CAR T-cell therapy is an immunotherapy used to treat certain types of cancers. CRS is an extreme immune response that causes easily-managed, flu-like symptoms in most patients. However, severe cases of CRS can result in life-threatening complications, including cardiac dysfunction, acute respiratory distress syndrome, or multi-organ failure.
According to a press release issued by Roche on August 31, Actemra and RoActemra are now approved to treat CAR T-cell induced severe or life-threatening CRS in patients two years of age and older.
“Until today, there has never been an FDA-approved treatment to manage severe cytokine release syndrome associated with CAR T- cell therapy, which is marked by a rapid onset and can cause life-threatening complications,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.
Actemra was initially approved by the FDA in 2010. Its other indications include:
In June, STAT published the findings of its own review of FDA adverse event reports related to Actemra and other RA medications. The examination revealed 13,000 reports involving Actemra, including cases of interstitial lung disease, heart attack, heart failure, stroke, and pancreatitis. The reports also linked Actemra to more than 1,100 deaths.
Prior to its initial approval in 2010, the FDA’s own reviewers voiced concerns about clinical data that suggested the Actemra could increase blood lipid levels, potentially resulting in an elevated risk of heart attacks and other cardiovascular events. The FDA only cleared Actemra on the condition that its manufacturers conduct long-term studies of its potential side effects.
While the labels for many other RA treatments, such as Humira, Remicade and Enbrel. include warnings for some of these side effects, Actemra’s does not. As such, many doctors and patients believe that Actemra is safer than its competitors.
STAT noted that The FDA has reviewed the safety of Actemra several times. However, the agency has so far ignored the recommendations of some of its own experts that the Actemra label should be modified to list other potential side effects and complications.