Pharmacyclics/Abbvie files sNDA at FDA for Imbruvica (ibrutinib) to treat patients with marginal zone lymphoma.

AbbVie has announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for Imbruvica (ibrutinib) to treat patients with marginal zone lymphoma (MZL).The Company's sNDA submission is based on data from a multi-center, open-label Phase II PCYC-1121-CA trial assessing ibrutinib as a single-agent treatment for MZL. If approved, MZL will be the fifth unique type of blood cancer indication for Imbruvica. Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.

Comment: Marginal zone lymphomas are a group of indolent (slow-growing) NHL B-cell lymphomas, which account for approximately 12 percent of all B-cell lymphomas. The median age for diagnosis is 65 years old. It presents primarily in sites such as stomach, bowel, salivary glands, lung, thyroid, lacrimal gland, conjunctiva, bladder, kidney, skin, soft tissue, thymus, breast. GI tract most is the most commonly involved. Within GI tract, stomach is involved in 85% cases .