資料來源：https://www.nasdaq.com/article/abbviejjs-imbruvica-label-expansion-filing-accepted-by-fda-cm770240

AbbVie and partner Janssen, Johnson & Johnson's pharmaceuticals subsidiary, announced that a supplemental new drug application (sNDA) for their cancer drug Imbruvica has been accepted for review by the FDA. AbbVie is looking to get Imbruvica approved for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after the failure of one or more lines of systemic therapy.

Imbruvica is presently approved for five indications. The drug is currently approved in the U.S. for the treatment of mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) in patients, who have received at least one previous therapy and for CLL patients with deletion 17p. It is also approved for the treatment of Waldenstrom's macroglobulinemia and relapsed/refractory marginal zone lymphoma.

If approved for cGVHD, Imbruvica will be the first medicine approved for the treatment of this disease, which is a serious and debilitating potential consequence of stem cell or bone marrow transplant. Meanwhile, it is also the first potential indication for Imbruvica outside of hematological malignancies. Imbruvica had orphan drug status as well as breakthrough therapy designation in the U.S. for this indication.

We remind investors that a registrational study for cGVHD showed positive results in Dec 2016 and formed the basis of the sNDA application.

Imbruvica was added to AbbVie's pipeline with the May 2015 acquisition of Pharmacyclics. It has become a key revenue driver for AbbVie and accounted for 7% of the company's sales in 2016. In 2017, AbbVie expects to record Imbruvica global revenues of more than $2.4 billion with sales in the U.S. expected to cross $2 billion. In fact, AbbVie expects Imbruvica peak sales of more than $7 billion and revenues of about $5 billion in 2020

At present, the CLL segment is the largest revenue contributor to Imbruvica's growth while expansion into non-Hodgkin's lymphoma (NHL) and other indications will be major growth drivers in the future.

Imbruvica has multi-billion dollar potential and AbbVie is exploring the potential to expand its label into solid tumors and autoimmune diseases. Imbruvica is in phase III studies for diffuse large B-cell lymphoma and follicular lymphoma. AbbVie is positioning Imbruvica as a "pipeline in a molecule" with the treatment featuring in several company-sponsored studies.