AbbVie plan to withdraw accelerated nods of Imbruvica in US for patients with certain types of blood cancer
IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.;
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North Chicago: AbbVie has announced the intent to voluntarily withdraw, in the U.S., accelerated IMBRUVICA (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma (MCL) who have received at least one prior therapy and with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
Other approved indications for IMBRUVICA in the U.S. are not affected. This voluntary action is due to requirements related to the accelerated approval status granted by the U.S. FDA for MCL and MZL. These indications were approved via this pathway based on overall response rates in Phase 2 clinical studies. To confirm clinical benefit following accelerated approvals, additional studies are required by the FDA.
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