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Zanubrutinib Plus Obinutuzumab Granted Accelerated Approval for Follicular Lymphoma

The FDA has granted accelerated approval to zanubrutinib (Brukinsa®, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This is the first approval of a Bruton tyrosine kinase (BTK) inhibitor for FL.   Why it matters: "FL is an indolent subtype of non-Hodgkin's lymphoma. While many attain complete remission with first-line treatment, the disease is characterized by a clinical course of serial relapses, with pa...

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Exploring Acalabrutinib Plus or Minus Obinutuzumab for CLL in the ELEVATE-TN Study With Jeff Sharman, MD

Oncology Data Advisor® · Exploring Acalabrutinib ± Obinutuzumab for CLL in the ELEVATE-TN Study: Jeff Sharman, MD Recently, at the American Society of Hematology (ASH) Annual Meeting, Dr. Jeff P. Sharman, the Medical Director of Hematology Research for Sarah Cannon Research Institute and the US Oncology Network, presented the long-term follow up results from the ELEVATE-TN study, which investigated acalabrutinib plus or minus obinutuzumab for previously untreated patients with ...

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Acalabrutinib in Chronic Lymphocytic Leukemia: Jeff Sharman, MD

​In patients with previously untreated chronic lymphocytic leukemia (CLL), the interim results of the phase 3 ELEVATE-TN trial have revealed that acalabrutinib (Calquence®, AstraZeneca) improves progression-free survival, either as monotherapy or in combination with obinutuzumab (Gazyva®, Genentech). This study led to the recent FDA approval of acalabrutinib for CLL and small lymphocytic lymphoma (SLL). In this interview with i3 Health, Jeff P. Sharman, MD, the trial's principal investigator, di...

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