publication date: Jan. 27, 2017

Drugs & Targets FDA approves first drug for marginal zone lymphoma

FDA approved the drug Imbruvica (imbrutinib) for the treatment of patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy.

Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech Inc.

Imbruvica is the first therapy specifically indicated for use in patients with relapsed/refractory MZL. This approval marks the fifth unique indication for Imbruvica in the U.S.

MZL accounts for approximately 12 percent of all cases of non-Hodgkin’s lymphoma in adults.

“This milestone marks the fifth patient population for whom Imbruvica is now approved and broadens the number of patients who may be treated with the medication,” said Darrin Beaupre, head of Early Development and Immunotherapy at Pharmacyclics LLC. “We continue to research Imbruvica across many disease areas, including, but not limited to, other B-cell malignancies.”

The approval in MZL is based on data from the phase II, open-label, multi-center, single-arm PCYC-1121 study, which evaluated the safety and efficacy of Imbruvica in MZL patients who require systemic therapy and have received at least one prior anti-CD20-based therapy.

The efficacy analysis included 63 patients with three sub-types of MZL: mucosa-associated lymphoid tissue (MALT; N=32), … Continue reading FDA approves first drug for marginal zone lymphoma

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