With a Monday decision by the FDA, adult patients with the rare blood cancer Waldenström's macroglobulinemia have a new, chemo-free treatment option in a combo of Imbruvica—a drug split by AbbVie and Johnson & Johnson—and Roche's Rituxan. Also with the approval, Imbruvica has another edge on AstraZeneca's Calquence.
The FDA signed off on the combo based on phase 3 data showing that it could significantly stave off cancer progression. In the study, dubbed Innovate, investigators recorded a 30-month progression-free survival figure of 82% for patients on the drug combo, compared with 28% for patients on Rituxan alone. Additionally, the combo reduced the incidence of anemia and infusion reactions that can be triggered by Rituxan use, Mark Wildgust, VP of global medical affairs for oncology at J&J's Janssen, previously told FiercePharma.
The combo “significantly improves outcomes, controls disease, improves the quality of life and addresses some of those symptomatic issues right up front,” Wildgust said this summer's American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Imbruvica is also approved solo to treat Waldenström's macroglobulinemia, but the new approval will eliminate the need for chemo as part of the regimen. The nod came about two months ahead of the FDA’s target decision date.
Imbruvica won its first nod in 2013 and has racked up several new uses since, grabbing additional nods in chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, marginal zone lymphoma and chronic graft-versus-host disease. That's not to say it hasn't stumbled, though; last month, it came up short in a non-Hodgkin lymphoma, failing to improve event-free survival in previously untreated diffuse large B-cell lymphoma patients.
A slow-growing form of non-Hodgkin's lymphoma, Waldenström's macroglobulinemia affects about 2,800 new patients in the U.S. every year.
The approval comes only two months after the combo picked up a priority review in Waldenström's macroglobulinemia. Meanwhile, AstraZeneca is advancing its rival Calquence in the patient group. In phase 2 data presented at ASCO, Calquence elicited an immune response in 93% of 106 previously untreated WM patients.
Already, AZ’s Calquence is challenging Imbruvica in mantle cell lymphoma, and the drugs are expected to additionally battle in chronic lymphocytic leukemia, one of Imbruvica's key markets.
AbbVie picked up its share of Imbruvica in its $21 billion buyout of Pharmacyclics in 2015. J&J and Pharmacyclics co-developed and co-market the drug.
For AbbVie, the drug represents an effort to diversify sales beyond the world’s bestselling med Humira, which pulled in more than $18 billion last year. Under recent patent settlements, biosimilars makers will have a chance to launch Humira copies in Europe this fall and in the U.S. in 2023.