FDA broadens Imbruvica label for CLL, SLL patients
Previously, CLL did not have any available treatments, and SLL gains a new indication with the drug label change. Thanks to overall survival data, gained from the company’s RESONATE-2 study, these patients may have access to the drug as a new treatment over chemotherapy.
"This update helps to affirm the established efficacy, safety and tolerability of this therapy for treatment of patients with CLL/SLL, both as a monotherapy or in combination with other agents," Jan Burger, RESONATE-2 lead study investigator, said. "It reflects the growing body of clinical evidence supporting this therapy as a potential treatment option for people living with CLL/SLL."
The modified label will also feature information from another trial, HELIOS. The trial provides brand new data that combine Imbruvica with rituximab and bendamustine for refractory or relapsed CLL and SLL patients.
"We are pleased the FDA has added the survival data observed with Imbruvica as a first-line therapy for CLL to its prescribing information and that the indication has been expanded to include patients with SLL,” Danelle James, head of oncology at Pharmacyclics, said. “Moreover, the positive results seen in the HELIOS study provide additional evidence supporting the compelling safety and efficacy seen with Imbruvica in CLL and SLL patients. We believe the Imbruvica label is very strong for the treatment of certain hematologic malignancies and is now reinforced not only by data evaluating its use as a single agent, but also in combination with other commonly used chemotherapy regimens."
Organizations in this story
AbbVie 1 N Waukegan Rd Lake Bluff, IL - 60044