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Approval Sought for Ibrutinib in Waldenström's Macroglobulinemia
Janssen Research & Development, LLC, has submitted a supplemental New Drug Application for ibrutinib (Imbruvica) as treatment for patients with Waldenström's macroglobulinemia (WM).
European Commission Approves Ibrutinib for MCL, CLL
Ibrutinib has been approved by the European Commission for the treatment of adult patients with relapsed or refractory MCL and adult patients with CLL.
Fast Track Designation Granted to TAS-102 in mCRC
The FDA has granted a fast track designation to TAS-102 (tipiracil hydrochloride) as a treatment for patients with refractory metastatic colorectal cancer (mCRC), according to an announcement by Taiho Oncology, the company developing the drug in the United States.
Oral Therapies Shift Treatment Paradigm in CLL
The treatment of patients with chronic lymphocytic leukemia (CLL) has undergone a dramatic transformation in the past year, with the approval of the novel oral agents ibrutinib (Imbruvica) and idelalisib (Zydelig).
New Treatment Strategies Emerge for Non-Small Cell Lung Cancer
The treatment of patients with non-small cell lung cancer (NSCLC) who harbor an actionable mutation in EGFR or ALK continues evolve, as clinical trials begin exploring next-generation agents and combination strategies.
Lenvatinib Receives Priority Review for RAI-Refractory DTC
The FDA has granted a priority review to the oral multiple tyrosine kinase receptor inhibitor lenvatinib as a treatment for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), according to the manufacturer of the drug, Eisai.
CAR Therapy Demonstrates Promise in ALL
The investigational chimeric antigen receptor (CAR) therapy CTL019 demonstrated promising activity in 2 pilot trials, eliciting complete remissions in 27 of 30 pediatric and adult patients (90%) with relapsed/refractory acute lymphoblastic leukemia (ALL).
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