Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
RARITAN, N.J., May 26, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 ANDROMEDA study, which evaluated DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare blood cell disorder associated with the deterioration of vital organs, most notably the heart, kidneys and liver.[1] Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO® in combi...
Source: Johnson and Johnson - May 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Reports 2020 Fourth-Quarter and Full Year Results
New Brunswick, N.J. (January 26, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2020. “Our notable full year performance reflects the continued confidence from patients, physicians, customers and consumers in our life-enhancing products and medicines, particularly throughout the COVID-19 pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m incredibly proud of our Johnson & Johnson teams around the world for going above and beyond to meet stakeholder needs. These efforts, and our commitment to families around the world as the largest broad-...
Source: Johnson and Johnson - January 26, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
FDA Approves First and Only Treatment for AL Amyloidosis FDA Approves First and Only Treatment for AL Amyloidosis
Accelerated approval has been granted to daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone for treatment of newly diagnosed light chain amyloidosis.FDA Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - January 20, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news
FDA Approves First and Only Treatment for AL Amyloidosis FDA Approves First and Only Treatment for AL Amyloidosis
Accelerated approval has been granted to daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone for treatment of newly diagnosed light chain amyloidosis.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 20, 2021 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news
DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterior...
Source: Johnson and Johnson - January 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma
December 21, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.“We are committed to innovation in cell therapy and advancing the science of multiple myeloma to improve patients’ lives,” said Peter Lebowitz, M.D....
Source: Johnson and Johnson - December 21, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
FDA approves selinexor for refractory or relapsed multiple myeloma
On December 18, 2020, the Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma
December 5, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today longer-term results from the combined Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of ciltacabtagene autoleucel (cilta-cel), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma. These data, presented as an oral presentation at the American Society of Hematology (ASH) 2020 Annual Meeting (Abstract #177), continued to demonstrate a very high ov...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Triplet Therapy Slows Refractory Multiple Myeloma
WEDNESDAY, Nov. 18, 2020 -- A once-weekly regimen of selinexor, bortezomib, and dexamethasone slows the progression of relapsed or refractory multiple myeloma, according to a study published in the Nov. 14 issue of The Lancet.
Sebastian Grosicki,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 18, 2020 Category: Pharmaceuticals Source Type: news
Homecare for Bortezomib Safe and Reduces Hospital Visits in Myeloma Patients Homecare for Bortezomib Safe and Reduces Hospital Visits in Myeloma Patients
Home administration of bortezomib by the patient or a relative is safe and reduces hospital visits for these immunosuppressed patients.Medscape News UK (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 11, 2020 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Janssen Headlines American Society of Hematology Annual Meeting With More Than 35 Presentations Highlighting Deep, Diverse Oncology Pipeline and Portfolio
RARITAN, N.J., November 5, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today more than 35 company-sponsored studies, including 10 oral presentations, will be featured at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.In multiple myeloma, highlights include Phase 1b/2 results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel); new and updated data for the anti-CD38 monoclonal antibody DARZALEX® (daratumumab) and the subcutaneous for...
Source: Johnson and Johnson - November 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
RVD Induction Therapy in Newly Diagnosed Multiple Myeloma RVD Induction Therapy in Newly Diagnosed Multiple Myeloma
What benefits might be achieved with a combination lenalidomide, bortezomib, and dexamethasone induction regimen in patients with multiple myeloma?Journal of Clinical Oncology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 17, 2020 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
Johnson & Johnson Reports 2020 Second-Quarter Results
New Brunswick, N.J. (July 16, 2020) – Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter 2020. “Our second quarter results reflect the impact of COVID-19 and the enduring strength of our Pharmaceutical business, where we saw continued growth even in this environment,” said Alex Gorsky, Chairman and Chief Executive Officer. “Thanks to the tireless work of our colleagues around the world and our broad range of capabilities, we continue to successfully navigate the external landscape, and we remain focused on advancing the development of a vaccine to help address this pandemic and save lives....
Source: Johnson and Johnson - July 16, 2020 Category: Pharmaceuticals Source Type: news
Subcutaneous Daratumumab Combination Resulted in Deep and Rapid Hematologic Responses and Improved Clinical Outcomes in the Treatment of Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
RARITAN, NJ, June 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the first randomized Phase 3 study investigating subcutaneous daratumumab[i] in the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare and potentially fatal disease.[1],[2] The data demonstrated subcutaneous daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) resulted in a higher hematologic complete response rate (CR), (53 percent vs. 18 percent [P<0.0001]), compared to CyBorD. Additionally, treatment with D-CyBorD delayed the time ...
Source: Johnson and Johnson - June 15, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Belantamab Mafodotin Triplet Yields Promising Clinical Benefit in Relapsed/Refractory Multiple Myeloma
The combination use of belantamab mafodotin plus bortezomib and dexamethasone induced high clinical benefit rates and a tolerable safety profile in patients with relapsed or refractory multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - June 8, 2020 Category: Cancer & Oncology Authors: Lisa Astor Source Type: news
