- The U.S. Food and Drug Administration has expanded the label for Janssen’s cancer drug Imbruvica (ibrutinib) to include updates survival data from two phase 3 studies, the Johnson and Johnson unit said.
- Results from the trials further supports Imbruvica’s first-line use to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
- In March, Imbruvica became the first FDA-approved chemotherapy-free treatment option for CLL patients, adding a fifth indication to its quiver.
Imbruvica received its first approval for treatment of mantle cell lymphoma in November 2013. Since then, it's been racking up approvals. In addition to its latest indication, Imbruvica is also approved for second-line treatment of CLL, CLL with 17p deletion, and Waldenström's macroglobulinemia (WM).
Janssen, working with co-developer AbbVie, hopes to further broaden the drug’s scope as a cancer treatment.
"The update helps to affirm the established efficacy, safety and tolerability of this therapy for the treatment of patients with CLL/SLL, both as a monotherapy or in combination with other agents. It reflects the growing body of clinical evidence supporting this therapy as a potential treatment option for people living with CLL/SLL,” said Jan Burger, lead investigator on one of the two studies.
In the Resonate-2 study, treatment with Imbruvica led to a statistically significant 56% reduction in the risk of death after a median follow up of 28 months, compared to the chemo agent chlorambucil. The study is evaluating the drug among treatment-naive CLL/SLL patients who are 65 and older.
The other study, called Helios, showed an 80% reduction in the risk of death for patients taking Imbruvica with bendamustine and rituximab (BR), compared to a placebo and BR.
Global sales of Imbruvica have increased steadily, notching a sequential quarterly gain in the first quarter and more than doubling compared to a year ago.