Janssen Seeks Approval of a New Indication for IMBRUVICA ® (ibrutinib) for Use in Patients with Untreated Mantle Cell Lymphoma
BEERSE, BELGIUM, 8 March 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for IMBRUVICA® (ibrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation (ASCT).Ibrutinib is a once-daily Bruton's tyrosine kinase (BTK) inhibitor that is currently approved for patients with MCL who have received at least one prior lin...
Source: Johnson and Johnson - March 8, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Data from Phase 3 GLOW Study Show Fixed-Duration Treatment with IMBRUVICA ® (ibrutinib) Plus Venetoclax Demonstrated Deeper and Sustained Undetectable Minimal Residual Disease Outcomes in First-Line Chronic Lymphocytic Leukemia
ATLANTA, Ga., December 11, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from two studies evaluating the efficacy and safety of IMBRUVICA® (ibrutinib) plus venetoclax (I+V) as a potential fixed-duration treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These data were both featured today during the American Society of Hematology (ASH) 2021 Annual Meeting. New secondary endpoint data from the Phase 3 GLOW study (NCT03462719) showed that fixed-duration treatment with I+V resulted in undetectable min...
Source: Johnson and Johnson - December 11, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Seeks Approval of IMBRUVICA ®(ibrutinib) in a Fixed-Duration Regimen for Patients with Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, 30 November 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new treatment option for IMBRUVICA® (ibrutinib) as a fixed-duration combination with venetoclax (I+V) for adult patients with previously untreated chronic lymphocytic leukaemia (CLL)."Ibrutinib was the first approved Bruton’s tyrosine kinase inhibitor and over the past seven years has become a key treatment for CLL and some other B-cell malignancies, treating more than 250,000 patients globally,...
Source: Johnson and Johnson - November 30, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Decades Spent Searching for Genes Linked to Rare Blood Cancer Decades Spent Searching for Genes Linked to Rare Blood Cancer
A National Cancer Institute researcher who has spent her entire career searching for a genetic link to Waldenstrom ' s macroglobulinemia has gleaned a few tantalizing clues.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - November 5, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Updated NCCN Guidelines Now Include Zanubrutinib for WM Updated NCCN Guidelines Now Include Zanubrutinib for WM
The new second-generation BTK inhibitor zanubrutinib is a preferred regimen for the treatment of symptomatic Waldenstrom ' s macroglobulinemia.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - November 4, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

When to Treat as Important as Which Drug to Use in WM When to Treat as Important as Which Drug to Use in WM
When to initiate treatment for patients newly diagnosed with Waldenstrom macroglobulinemia (WM) is as important as which drug to use, says expert.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - October 29, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

FDA Approval for Zanubrutinib in Waldenstr öm’s Macroglobulinemia FDA Approval for Zanubrutinib in Waldenstr öm’s Macroglobulinemia
The US Food and Drug Administration has approved zanubrutinib for use in the treatment of adult patients with a rare form of non-Hodgkin lymphoma.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 2, 2021 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

FDA approves zanubrutinib for Waldenstr öm’s macroglobulinemia
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 - September 1, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

U.S. FDA Grants Brukinsa (zanubrutinib) Approval in Waldenstr öm’s Macroglobulinemia
CAMBRIDGE, Mass.& BEIJING, September 01, 2021--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that Brukinsa... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 1, 2021 Category: Drugs & Pharmacology Source Type: news

How Long Can You Live With Waldenstrom's Macroglobulinemia?
Title: How Long Can You Live With Waldenstrom ' s Macroglobulinemia?Category: Diseases and ConditionsCreated: 8/24/2021 12:00:00 AMLast Editorial Review: 8/24/2021 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - August 24, 2021 Category: Cancer & Oncology Source Type: news

Zydus Cadila gets tentative nod from USFDA to market cancer drug
"Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia," Zydus Cadila said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 21, 2021 Category: Pharmaceuticals Source Type: news

Country music star Ashley Monroe reveals rare blood cancer diagnosis
Pistol Annies member Ashley Monroe told fans she had been diagnosed with Waldenstrom Macroglobulinemia. The singer opened up about how... (Source: Reuters: Health)
Source: Reuters: Health - July 13, 2021 Category: Consumer Health News Source Type: news

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

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