Wednesday, August 16, 2017 -- AstraZeneca and Acerta Pharma's treatment for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration.“New treatments are urgently needed for people with mantle cell lymphoma who relapse or do not respond to therapy,” Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, said in a statement. “Breakthrough Therapy Designation for acalabrutinib will help us bring this potential medicine to appropriate patients as quickly as possible.”The designation will help expedite the development and regulatory review; it’s given by the FDA to new medicines designed to treat serious conditions and that have shown positive early results.“This is an
Thursday, August 17, 2017 -- Seattle Genetics reported that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
Thursday, August 17, 2017 -- Central nervous system (CNS) relapses are an uncommon yet devastating complication of non-Hodgkin lymphomas. The identification of patients at high risk of secondary CNS relapse is therefore paramount. Retrospective data indicate prophylactic CNS-directed therapies may reduce the risk of CNS involvement; however, no consensus exists about dose, timing, or route of therapy. In addition, prophylaxis is not without risk of treatment-related complications and morbidity. Here, we present a series of case vignettes highlighting our approach to common dilemmas encountered in routine clinical practice. We review the method of assessing CNS relapse risk, factors that increase the likelihood of relapse including histologic subtype, MYC rearrangement, protein expression, and extranodal involvement, and review our clinical practice based on available evidence in
Monday, August 14, 2017 -- Get the most up-to-date treatment regimens for adult T-cell leukemia/lymphoma (a non-Hodgin leukemia), such as zidovudine + alpha-interferon.
Wednesday, August 16, 2017 -- The FDA granted priority review to brentuximab vedotin for the treatment of cutaneous T-cell lymphoma, according to the drug’s manufacturer.The agency set a target action date of Dec. 16.