Bluebird Bio says Lyfgenia label includes boxed warning

Bluebird Bio says the safety information for Lyfgenia included a boxed warning for hematologic malignancy. The most common adverse reactions greater than or equal to Grade 3 were stomatitis, thrombocytopenia, neutropenia, febrile neutropenia, anemia, and leukopenia. As previously reported, three patients died during Lyfgenia clinical trials; one from sudden cardiac death due to underlying disease and two from acute myeloid leukemia who were treated with an earlier version of Lyfgenia using a different manufacturing process and transplant procedure, the company said in a statement. Hematologic malignancy has occurred in patients treated with LLyfgenia, it added. The label says to monitor patients “closely for evidence of malignancy through complete blood counts at least every 6 months and through integration site analysis at Months 6, 12, and as warranted.” Shares of Bluebird Bio are up 7% to $5.17 following the approval.