November 20th 2024
The FDA updated the fludarabine phosphate injection labeling under Project Renewal, clarifying the dosage for combination therapy and streamlining safety warnings.
November 13th 2024
Acalabrutinib Sustains Benefit In Patients With R/R CLL After 42 Months
December 10th 2019Ongoing benefits of 42 months were observed with Bruton’s tyrosine kinase inhibitor acalabrutinib treatment in patients with relapsed/refractory chronic lymphocytic leukemia, according to long-term follow-up data from the phase I/II ACE-CL-001 study reported at the 2019 American Society of Hemetology Annual Meeting.
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42-Month Follow-Up Data of Acalabrutinib Monotherapy in R/R CLL
December 10th 2019<br /> Richard R. Furman, MD, professor of medicine, Morton Coleman, MD Distinguished Professor of Medicine, director, Chronic Lymphocytic Leukemia Research Center, Weill Cornell Medicine, and attending physician, NewYork-Presbyterian Hospital, discusses the 42-month follow-up data of acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia.
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Long-Term Follow-Up Supports Early Use of Ibrutinib in CLL
December 10th 2019Data from up to 6 years of long-term follow-up shows better progression-free survival, overall survival, objective response rates, and sustained efficacy for patients with chronic lymphocytic leukemia who receive single-agent ibrutinib in earlier lines of treatment, including those with high-risk prognostic factors. According to the poster presented by Paul M. Barr, MD, Division of Hematology/Oncology, Wilmot Cancer Institute, University of Rochester, Rochester, NY, during the 2019 American Society of Hematology Annual Meeting, first-line ibrutinib yielded deeper responses over time with 30% complete responses versus 10% to 12% CR for later lines of treatment.
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Liso-Cel Shows Promising Clinical Activity and Safety in CLL/SLL
December 9th 2019Patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma who previously progressed on ibrutinib, responded well to treatment the CD19-directed CAR T-cell therapy lisocabtagene maraleucel and had manageable toxicity, according to updated findings from the phase I/II TRANSCEND CLL 004 study presented at the 2019 American Society of Hematology Annual Meeting and Exposition.
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Zanubrutinib Highly Effective in CLL/SLL, Despite Presence of High-Risk Cytogenetics
December 9th 2019In the SEQUOIA trial, zanubrutinib, a Bruton’s tyrosine kinase inhibitor, showed continued high overall response rates for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, regardless of deletion 17p status, according to findings presented at the American Socitey of Hematology Annual Meeting and Exposition.
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Triplet Therapy Induced CR in R/R CLL
December 9th 2019In a phase I/II dose escalation study, there was a complete remission rate of 44% in patients with relapsed/refractory chronic lymphocytic leukemia receiving umbralisib, ublituximab, and venetoclax, according to findings presented at the 2019 ASH Annual Meeting.
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Fixed-Duration Venetoclax Plus Obinutuzumab Improves PFS With High Undetectable MRD Rates in CLL
December 9th 2019Fixed-duration treatment with the combination of venetoclax plus obinutuzumab results in superior progression-free survival and high rates of undetectable minimal residual disease in patients with previously untreated chronic lymphocytic leukemia than chlorambucil plus obinutuzumab.
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Triplet Therapy With Acalabrutinib Has Activity in Chronic Lymphocytic Leukemia
December 8th 2019An open-label, single-arm, phase II study in patients with chronic lymphocytic leukemia demonstrated the frontline AVO triplet, comprised of acalabrutinib, venetoclax, and obinutuzumab, achieved undetectable minimal residual disease in the bone marrow in 48% of patients after only 8 monthly cycles of therapy, according to lead author Benjamin L. Lampson, MD, PhD, who presented the findings at the 2019 ASH Annual Meeting.
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Favorable PFS Continues to be Observed With Ibrutinib/Rituximab in CLL
December 8th 2019Updated follow-up analysis of the phase III E1912 study showed that ibrutinib/rituximab induced higher rates of progression-free survival (PFS) when compared against fludarabine, cyclophosphamide, and rituximab in patients ≤70 years with previously untreated chronic lymphocytic leukemia (CLL), according to Tait D. Shanafelt, MD, who presented the findings at the 2019 ASH Annual Meeting.
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Undetectable MRD Is Reached in Patients With CLL Receiving First-Line Ibrutinib/Venetoclax
December 8th 2019Patients <70 years old with chronic lymphocytic leukemia treated in the minimal residual disease (MRD)–cohort of the phase II CAPTIVATE trial had undetectable MRD rates of 75% and 72% in the peripheral blood and bone marrow, respectively, with the frontline combination of ibrutinib and venetoclax, according to findings presented at the 2019 ASH Annual Meeting.
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Patients With CLL Treated on the ELEVATE-TN Trial Experience Improved PFS With Acalabrutinib
December 8th 2019Patients with treatment-naïve chronic lymphocytic leukemia experienced a statistically significant improvement in progression-free survival with acalabrutinib as a single agent or in combination with obinutuzumab when compared with obinutuzumab plus chlorambucil, according to results from the phase III ELEVATE-TN trial presented at the 2019 ASH Annual Meeting.
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A Look Back at FDA News from November 2019
December 2nd 2019In November 2019, the FDA approved a number of treatments, including acalabrutinib for the treatment of chronic lymphocytic leukemia and small lymphocytic leukemia, as well as zanubrutinib for the treatment of mantle cell lymphoma. A biosimilar for pegfilgrastim was also approved under indications.
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Age Impacts Treatment Options for Patients With CLL
November 21st 2019Kanti R. Rai, MD, professor of medicine, Northwell Health and Zucker School of Medicine at Hofstra University, explains the importance of attention to age when treating patients with chronic lymphocytic leukemia, which is a typically elderly patient population.
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Optimizing Use of Prognostic Markers for the Treatment of CLL
November 20th 2019In an interview with Targeted Oncology at the 2019 Chemotherapy Foundation Symposium, Richard R. Furman, MD, reviewed his presentation on prognostic markers and their importance in the treatment of patients with chronic lymphocytic leukemia.
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Ibrutinib/Rituximab Seeking Approval As Frontline Treatment for CLL
November 13th 2019A supplemental New Drug Application for the combination of ibrutinib and rituximab has been submitted to the FDA for the first-line treatment of patients aged 70 years or younger with chronic lymphocytic leukemia or small lymphocytic lymphoma, according to a press release from ibrutinib developer, AbbVie.
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Dynamic Tumor Cell Profiling Technique Correlates With Therapy Responses
November 8th 2019A technique involving BH3 profiling is emerging as a promising drug discovery tool for assessing whether a tumor is primed for cell death and would respond to anticancer therapy, according to a presentation at the 2019 Association for Molecular Pathology Annual Meeting.
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Long-Term Ublituximab Plus Ibrutinib Results Show PFS Benefit in High-Risk CLL
October 25th 2019Ublituximab in combination with ibrutinib demonstrated a benefit in progression-free survival over ibrutinib monotherapy, as assessed by an independent review committee, in patients with high-risk relapsed or refractory chronic lymphocytic leukemia in the final long-term results of the phase III GENUINE trial.
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Durable Responses Demonstrated in Phase I/II With U2 Triplet Regimen in CLL
September 28th 2019Umbralisib and ublituximab in combination with pembrolizumab was well tolerated among patients with relapsed/refractory chronic lymphocytic leukemia and Richter’s transformation, according to a phase I/II trial presented at the 18th International Workshop on CLL. Responses were durable in high-risk patients who are BTK-refractory, including 2 complete responses in patients with RT.
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Favorable Safety Profile Demonstrated With Umbralisib in Pretreated CLL
September 25th 2019The PI3K-delta inhibitor umbralisib demonstrated a favorable toxicity profile as treatment for patients with chronic lymphocytic leukemia who have become intolerant to a prior kinase inhibitor, of either BTK or PI3K inhibition, according to results from a phase II study presented at the 18th International Workshop on CLL.
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Acalabrutinib Shows High Response, Prolonged Survival in Ibrutinib-Intolerant R/R CLL
September 24th 2019Bruton tyrosine kinase inhibitor acalabrutinib demonstrated a high rate of response, prolonged survival, and high tolerability in patients with chronic lymphocytic leukemia who demonstrated intolerance to ibrutinib. Findings were presented at the 15th International Conference on Malignant Lymphoma.
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Genetic Analysis Provides Insight Into Venetoclax/Obinutuzumab Benefit in Frontline CLL
September 18th 2019Rate of response and progression-free survival were superior with venetoclax versus chlorambucil in patients with chronic lymphocytic leukemia who also received obinutuzumab, and this trend was observed across all genetic subgroups.<br />
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Novel Combination Therapies in CLL Transform the Treatment Landscape
September 15th 2019The presence of novel combinations and oral targeted therapies are rising in the frontline treatment setting for patients with chronic lymphocytic leukemia, regardless of age. According to Nitin Jain, MD, ongoing phase III trials will bring additional modifications to the treatment landscape.
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