منابع مشابه
Idelalisib, ibrutinib show benefits in CLL.
challenging in general, not only for children’s cancers,” says Chesler. “To encourage commercial development, the EMA should consider creative and more robust ways of working with pharma, academia, and government to make the PIP scheme more effi cient.” The FDA and the EMA already share information and communicate regularly about promising drugs, says Reaman. “It’s possible for the FDA and the ...
متن کاملEvolution of ibrutinib resistance in chronic lymphocytic leukemia (CLL).
The Bruton tyrosine kinase inhibitor (BTKi) ibrutinib is a new targeted therapy for patients with chronic lymphocytic leukemia (CLL). Ibrutinib is given orally on a continuous schedule and induces durable remissions in the majority of CLL patients. However, a small proportion of patients initially responds to the BTKi and then develops resistance. Estimating the frequency, timing, and individua...
متن کاملFDA grants accelerated approval for ibrutinib for CLL.
The US Food and Drug Administration (FDA) on Wednesday granted accelerated approval for the expanded use of ibrutinib, marketed as Imbruvica, for chronic lymphocytic leukemia (CLL) patients who have previously received at least one therapy. This approval was based on a phase 1b-2 open-label, multicenter study that was designed to determine the safety, efficacy, pharmacokinetics, and pharmacodyn...
متن کاملp53-independent ibrutinib responses in an Eμ-TCL1 mouse model demonstrates efficacy in high-risk CLL
Deletion of the short-arm of chromosome 17 (17p-) is one of the most critical genetic alterations used in chronic lymphocytic leukemia (CLL) risk stratification. The tumor suppressor TP53 maps to this region, and its loss or mutation accelerates CLL progression, hampers response to chemotherapy and shortens survival. Although florescent in situ hybridization analyses for 17p deletions are routi...
متن کاملIdentification of a structurally novel BTK mutation that drives ibrutinib resistance in CLL
Ibrutinib (ibr), a first-in-class Bruton tyrosine kinase (BTK) inhibitor, has demonstrated high response rates in both relapsed/refractory and treatment naïve chronic lymphocytic leukemia (CLL). However, about 25% of patients discontinue ibrutinib therapy at a median follow-up of 20 months and many patients discontinue the treatment due to leukemia progression or Richter transformation. Mutatio...
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ژورنال
عنوان ژورنال: Nature Reviews Clinical Oncology
سال: 2019
ISSN: 1759-4774,1759-4782
DOI: 10.1038/s41571-019-0265-6