New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of re...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia
Hematology / Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Roche announces data at EHA2021 reinforcing efficacy of Venclexta/Venclyxto combinations in chronic lymphocytic leukaemia and acute myeloid leukaemia
Basel, 11 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the latest data from three pivotal phase III studies of Venclexta ®/Venclyxto® (venetoclax) – CLL14, MURANO and VIALE-A – to be presented at the European Hematology Association Virtual Congress, June 9-17 (EHA2021). Long-term follow-up data from the CLL14 and MURANO studies support the primary analysis of Venclexta/Venclyxto in chronic lymphocytic leukaemia (CLL) and the possibility of tailoring treatment approaches based on genetic risk factors. Furthermore, the latest research shows the potential of minimal residual disease (MRD) as a key meas...
Source: Roche Media News - June 11, 2021 Category: Pharmaceuticals Source Type: news
Roche announces data at EHA2021 reinforcing efficacy of Venclexta/Venclyxto combinations in chronic lymphocytic leukaemia and acute myeloid leukaemia
Basel, 11 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the latest data from three pivotal phase III studies of Venclexta ®/Venclyxto® (venetoclax) – CLL14, MURANO and VIALE-A – to be presented at the European Hematology Association Virtual Congress, June 9-17 (EHA2021). Long-term follow-up data from the CLL14 and MURANO studies support the primary analysis of Venclexta/Venclyxto in chronic lymphocytic leukaemia (CLL) and the possibility of tailoring treatment approaches based on genetic risk factors. Furthermore, the latest research shows the potential of minimal residual disease (MRD) as a key meas...
Source: Roche Investor Update - June 11, 2021 Category: Pharmaceuticals Source Type: news
Combination targeted therapy provides durable remission for patients with CLL
(University of Texas M. D. Anderson Cancer Center) A combination of ibrutinib and venetoclax was found to provide lasting disease remission in patients with newly diagnosed chronic lymphocytic leukemia (CLL), according to researchers at The University of Texas MD Anderson Cancer Center. Findings from the single-institution Phase II study were published today in JAMA Oncology and provide the longest follow-up data on patients treated with this drug regimen. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - June 10, 2021 Category: Cancer & Oncology Source Type: news
Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 30 company-sponsored studies, including six oral presentations, will be featured during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8. Janssen presentations will include new data and updates for both approved and investigational therapeutics that are being studied for the treatment of various solid tumors and blood cancers. Immediately following ASCO, additional data will be featured during the European Hematology Association (EHA) Virtual Congress, June 9-17. A comp...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Ibrutinib for chronic lymphocytic leukaemia in Italy: high discontinuation rates for costly therapy
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - June 1, 2021 Category: Drugs & Pharmacology Source Type: news
Oncotarget: STAT3 induces the expression of GLI1 in chronic lymphocytic leukemia cells
(Impact Journals LLC) Chronic lymphocytic leukemia (CLL) is characterized by gradual accumulation of neoplastic B cells. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - May 31, 2021 Category: Cancer & Oncology Source Type: news
TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the Company’s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 25, 2021 Category: Drugs & Pharmacology Source Type: news
IMBRUVICA ® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the fixed-duration cohort of the investigational Phase 2 CAPTIVATE study, showing that 95 percent of patients treated with combined IMBRUVICA® plus venetoclax were alive and progression-free at two years.[1] Deep remissions were seen across all subgroups, including patients with high-risk chronic lymphocytic leukemia (CLL).1 In addition, long-term data from the RESONATE-2 (PCYC-1115/1116) study will be presented, providing the longest follow-up Phase 3 data for any BTK inhibitor to date. These data ...
Source: Johnson and Johnson - May 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Efficacy of BNT162b2 mRNA COVID-19 Vaccine Lower in Patients With CLL
THURSDAY, May 6, 2021 -- The BNT162b2 mRNA COVID-19 vaccine has lower efficacy among patients with chronic lymphocytic leukemia (CLL) and induces lower neutralizing antibody responses (NAbs) in elderly patients with multiple myeloma (MM) versus... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 6, 2021 Category: Pharmaceuticals Source Type: news
Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Bas ed on this positive CHMP recommendation, a final decision regarding the approval of Venclyxto in certain patients with untreated AML is expected from the European Commission in the near future.“Today’s recommendation...
Source: Roche Investor Update - April 23, 2021 Category: Pharmaceuticals Source Type: news
GENUINE Improvements: Ublituximab Plus Ibrutinib for CLL GENUINE Improvements: Ublituximab Plus Ibrutinib for CLL
Chronic lymphocytic leukemia (CLL) expert Jennifer R. Brown, MD, discusses the recently published GENUINE trial and its implications for treating high-risk patients.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 20, 2021 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Studies suggest people with blood cancers may not be optimally protected after COVID-19 vaccination
(American Society of Hematology) Two new studies published in Blood suggest that the mRNA COVID-19 vaccine may have reduced efficacy in individuals with chronic lymphocytic leukemia (CLL) and multiple myeloma, two types of blood cancer. According to researchers, these studies could help inform the ideal time for vaccination of these populations. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - April 16, 2021 Category: Infectious Diseases Source Type: news
EU Panel Endorses Duvelisib for CLL and Follicular Lymphoma EU Panel Endorses Duvelisib for CLL and Follicular Lymphoma
The panel recommends EU approval for duvelisib (Copiktra) for certain patients with chronic lymphocytic leukemia (CLL) or follicular lymphoma.International Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 29, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news
