AbbVie (NYSE:ABBV) and Janssen Pharmaceutical (NYSE:JNJ) have revealed their intent to voluntarily withdraw the accelerated approvals for Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S.  Ibrutinib is a selective Bruton’s tyrosine kinase (BTK). The main reasons for the move relate to FDA’s request for additional studies…

Johnson & Johnson‘s Janssen unit (NYSE:JNJ) has filed a submission of a Type II variation application to the European Medicines Agency (EMA) for the potential approval of Imbruvica (ibrutinib) with bendamustine and rituximab (BR) to treat adults with previously untreated mantle cell lymphoma (MCL). The indication would cover patients who are not suitable for autologous…