Imbruvica finds new use as GvHD drug
- AbbVie and partner Johnson & Johnson announced Wednesday afternoon that the Food and Drug Administration approved their blood cancer drug Imbruvica for the treatment of chronic graft-versus-host disease (cGvHD) after failure of one or more treatments.
- The life-threatening condition can occur in patients after receiving a stem cell transplant from blood or bone marrow and happens when the stem cells attack the host cells. The infection occurs in 30% to 70% of these patients, according to the FDA.
- The Bruton's tyrosine kinase (BTK) inhibitor was initially approved in 2013 and is now approved to treat a variety of lymphomas and leukemias.
Imbruvica (ibrutinib) is one of Johnson & Johnson's fastest growing therapies, with more than 50% growth year over year in the first six months of 2017. The multinational conglomerate reported sales for Imbruvica of $859 million for the first half. AbbVie, meanwhile, recorded sales of $1.2 billion for the first six months.
AbbVie commercializes the drug in the U.S. co-exclusively with Janssen, though AbbVie is lead in end customer product sales. J&J is responsible for commercialization outside of the U.S and pre-tax profits are shared equally between the two companies in both geographies.
The companies have high hopes for the drug — it was one of the main drivers behind AbbVie's $21 billion acquisition of Pharmacyclics in 2015. Analysts have estimated the drug could have peak sales as high as $7 billion and AbbVie has put estimates at $5 billion by 2020.
While the drug is doing exceedingly well, more BTK inhibitors are entering the market and the hematology space is becoming increasingly crowded.
Yet, cGvHD had no other approved treatments. Currently, patients are treated with corticosteroids if they development the condition after surgery. The new indication for Imbruvica requires that patients try the steroids before using the cancer treatment.
"This approval highlights how a known treatment for cancer is finding a new use in treating a serious and life-threatening condition that may occur in patients with blood cancer who receive a stem cell transplant," said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
While the safety of the drug has been borne out through both clinical trials and use in patients while on the market, the approval in cGvHD was based on a single-arm, 42-patient study — 67% of patients saw improvement in symptoms and 48% were still showing those improvements more than five months later.
A Phase 3 study to examine Imbruvica with corticosteroid compared to placebo with corticosteroid as a first-line therapy for patients with new onset moderate or severe cGVHD began in December 2016. The study is currently ongoing.
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