Chronic Lymphocytic Leukemia

In 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.

Thomas Kipps, MD, PhD, discusses the chronic lymphocytic leukemia treatment spectrum and the explosion of targeted therapies in the field. 

Matthew S. Davids, MD, MMSc, discusses the rapid developments in the chronic lymphocytic leukemia treatment landscape.

The treatment spectrum for chronic lymphocytic leukemia has expanded significantly with the development and approval of several new agents.

The FDA has approved acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma as either an initial or subsequent therapy.

Kanti 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.

In 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.

A 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.

A 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.

Ublituximab 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.

William G. Wierda, MD, PhD, shares a message with community oncologists about the evolving treatment landscape for patients with chronic lymphocytic leukemia.

Umbralisib 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.

The 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.

Bruton 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.

Rate 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 /> &nbsp;

Tanya Siddiqi, MD, discusses how she sees acalabrutinib fitting into the treatment landscape for patients with chronic lymphocytic leukemia following the results from the phase III ASCEND trial.

The 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.

Two analyses of the phase II DUO trial show that modifying the dosage of duvelisib or interrupting treatment in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, does not compromise outcomes or increase toxicity.

Here&#39;s a look back on the FDA happenings for the month of August 2019, including FDA approvals, priority reviews, and breakthrough designations.

David Bond, MD, discusses 2 key findings from a recent study investigating the risk of developing a second cancer in patients with chronic lymphocytic leukemia treated with a BTK inhibitor.

In an interview with&nbsp;Targeted Oncology, Alessandra Tedeschi, MD, discussed the 5-year data she presented at the 2019 EHA Meeting for frontline ibrutinib as a treatment for patients with CLL. She also highlighted other research that may also benefit elderly patients with CLL, including the emerging combination of venetoclax and obinutuzumab.

The FDA has granted a breakthrough therapy designation to acalabrutinib monotherapy for the treatment of adult patients with chronic lymphocytic leukemia.&nbsp;The breakthrough designation was given based on the results of interim analyses from 2 phase III trials: ELEVATE-TN and ASCEND.&nbsp;

The initial pilot study of CTL019 in heavily pretreated CD19-positive hematologic malignancies demonstrated the feasibility of CAR T-cell therapy in patients with CLL. A presentation at the 2019 American Society of Gene &amp; Cell Therapy Annual Meeting reported 2 cases of chemotherapy-resistant CLL, with ongoing follow- up at 8 years showing persistence of CAR-engineered T cells and sustained remission, as determined by flow cytometry and deep sequencing of immunoglobulin H rearrangements.&nbsp;

In the phase I/II TRANSCEND CLL 004 study, chimeric antigen receptor T-cell therapy lisocabtagene maraleucel led to undetectable minimal residual disease in patients with relapsed/refractory chronic lymphocytic leukemia.

Take a look back on the FDA happenings, including approvals, fast track designations, priority reviews, and more from the month of July 2019.