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 th...
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 Pete...
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 hig...
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 subcutane...
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...
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
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

ASCO Expert Discusses Clinical Benefit of Combination for Relapsed/Refractory Multiple Myeloma
Ajay K. Nooka, MD, MPH, FACP discussed the clinical benefits of belantamab mafodotin in combination with bortezomib/dexamethasone to treat multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - June 2, 2020 Category: Cancer & Oncology Authors: Ajay K. Nooka, MD Source Type: news

Addition of Selinexor to Bortezomib, Dexamethasone Improves Responses in Myeloma
The addition of selinexor, a selective inhibitor of nuclear export, to bortezomib and dexamethasone improved progression-free survival across all subgroups in a study of pretreated patients with multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - May 29, 2020 Category: Cancer & Oncology Authors: Beth Fand Incollingo Source Type: news

Carfilzomib Triplet Therapy Shows Inferior PFS in Newly Diagnosed Multiple Myeloma
Carfilzomib combined with lenalidomide and dexamethasone failed to improve progression-free survival, compared with the current standard of care triplet of bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - May 29, 2020 Category: Cancer & Oncology Authors: Jessica Skarzynski Source Type: news

Carfilzomib does not improve outcomes in newly diagnosed myeloma compared to bortezomib
(ECOG-ACRIN Cancer Research Group) The combination of carfilzomib, lenalidomide, and dexamethasone (KRd) did not improve progression-free survival in patients with newly diagnosed myeloma absent a high-risk disease prognosis, compared with the standard of care -- bortezomib, lenalidomide, and dexamethasone (VRd). The data from a planned interim analysis for the ENDURANCE (E1A11) randomized phase three trial will be presented at the ASCO 2020 plenary. KRd had more severe cardiac, pulmonary, and renal toxicities. Neuropathy was more common among those receiving VRd. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 28, 2020 Category: International Medicine & Public Health Source Type: news

Janssen ’s BCMA CAR-T Therapy JNJ-4528 Showed Early, Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
RARITAN, NJ, May 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ-4528, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in the treatment of patients with relapsed or refractory multiple myeloma. Longer-term follow-up results from the Phase 1b portion of the study (n=29), to be shared in an oral presentation at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (Abstract #8505), show t...
Source: Johnson and Johnson - May 14, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Transplant Beats Bortezomib-Based Therapy for MM Transplant Beats Bortezomib-Based Therapy for MM
In a large randomized trial, upfront autologous transplantation bested bortezomib-based intensification therapy for patients with multiple myeloma.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - May 8, 2020 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Johnson & Johnson Reports 2020 First-Quarter Results:
New Brunswick, N.J. (April 14, 2020) – Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2020. The Company also announced earlier today that its Board of Directors declared a 6.3% increase in the quarterly dividend rate, from $0.95 per share to $1.01 per share. At the new rate, the indicated dividend on an annual basis is $4.04 per share compared to the previous rate of $3.80 per share. “With Johnson & Johnson’s century-plus history of leading in times of great challenge, we are mobilizing our resources across the Company in the fight against the COVID-19 pandemic,” sai...
Source: Johnson and Johnson - April 14, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Peter Voorhees, MD, Discusses Results from the Ongoing GRIFFIN Study
The study is evaluating daratumumab plus lenalidomide, bortezomib, and dexamethasone in autologous stem cell transplant eligible patients newly diagnosed with multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - February 18, 2020 Category: Cancer & Oncology Authors: Peter Voorhees, MD Source Type: news

Janssen Announces Submission to U.S. FDA for New DARZALEX ® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma
RARITAN, NJ, February 10, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. The sBLA is supported by results from the Phase 3 CANDOR study, which compared treatment with DKd to carfilzomib and dexamethasone (Kd) in patients with multiple myeloma who relapsed after one to three prior lines of therapy. “W...
Source: Johnson and Johnson - February 10, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Featured Review: Reducing uncertainties in choosing first-line treatment in newly diagnosed multiple myeloma
Multiple myeloma is a type of blood cancer. It accounts for approximately 2% of all cancers and is still considered incurable. For people with newly diagnosed multiple myeloma (NDMM), who are unsuitable for a procedure where damaged blood cells are replaced with healthy ones (stem-cell transplant), treatment is usually a multiple drug combination of bortezomib, lenalidomide, or thalidomide, plus melphalan and prednisolone (MP) or dexamethasone (D). Multiple drug combinations are approved for initial anti-myeloma therapy, however, access to these medicines is restricted in many countries worldwide.The Cochrane Review used n...
Source: Cochrane News and Events - November 26, 2019 Category: Information Technology Authors: Katie Abbotts Source Type: news

FDA Approves Darzalex (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma
HORSHAM, Pa., September 26, 2019– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the U.S. Food and Drug Administration (FDA) approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 26, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Darzalex Combo as Frontline Treatment for Myeloma
The combination use of Darzalex with bortezomib, thalidomide, and dexamethasone was approved for transplant-eligible patients with multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - September 26, 2019 Category: Cancer & Oncology Authors: Seth Augenstein Source Type: news

Could Adding Bortezomib Have Benefit for High-Risk Follicular Lymphoma?
The CALGB 50904 trial tested the addition of bortezomib to ofatumumab and bendamustine in patients with previously untreated high-risk follicular lymphoma. (Source: CancerNetwork)
Source: CancerNetwork - June 25, 2019 Category: Cancer & Oncology Authors: Leah Lawrence Source Type: news

Daratumumab + European Standard Yields Clinical Benefit in Transplant Eligible, Newly Diagnosed Myeloma
New data from the CASSIOPEIA trial evaluated the  use of daratumumab in addition to bortezomib/thalidomide/dexamethasone after ASCT in multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - June 3, 2019 Category: Cancer & Oncology Authors: Leah Lawrence Source Type: news

i-Fect Scores Again
This study is the first to demonstrate that the stabilization of HIF1A expression underpins the development of bortezomib-induced neuropathic pain. Crucially, these findings reveal that the initiation and maintenance of bortezomib-induced neuropathic pain are regulated by distinct mechanisms. (Source: Neuromics)
Source: Neuromics - May 13, 2019 Category: Neuroscience Tags: chemotherapy i-Fect RNAi siRNA siRNA delivery in-vivo Source Type: news

i-Fect in Action
This study is the first to demonstrate that the stabilization of HIF1A expression underpins the development of bortezomib-induced neuropathic pain. Crucially, these findings reveal that the initiation and maintenance of bortezomib-induced neuropathic pain are regulated by distinct mechanisms.Looking to up your odds for high percentage siRNA Transfection? Try i-Fect. (Source: siRNA and DsiRNA Transfection Efficiency)
Source: siRNA and DsiRNA Transfection Efficiency - May 9, 2019 Category: Neuroscience Tags: Chemotherapy i-Fect in vivo RNAi neuropathic pain siRNA delivery in-vivo Source Type: news

Myeloma Patients Could Self-Administer Bortezomib at Home Myeloma Patients Could Self-Administer Bortezomib at Home
Multiple myeloma patients or even their relatives can be taught to safely self-administer bortezomib at home, reducing both the time they spend at the clinic and resource use, say UK researchers.Medscape News UK (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 2, 2019 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

World Cancer Day
is an international day marked on February 4 to raise awareness of cancer and to encourage its prevention, detection, and treatment. 2019 marks the launch of the 3-year ‘I Am and I Will’ campaign; an empowering call-to-action urging for personal commitment and represents the power of individual action taken now to impact the future.Cochrane Cancer supports and coordinates the work acrossmultiple Cochrane Review Groups dealing with the topic of Cancer. These  Cochrane Review Groups provide reliable evidence required to make important decisions on issues concerning cancer and related topics. Cochrane R...
Source: Cochrane News and Events - January 14, 2019 Category: Information Technology Authors: Muriah Umoquit Source Type: news

Bortezomib-Based Therapy Effective for Relapsed/Refractory Myeloma
Relapsed or refractory multiple myeloma patients experience high response rates, overall survival with bortezomib-based therapy. (Source: CancerNetwork)
Source: CancerNetwork - August 13, 2018 Category: Cancer & Oncology Authors: Leah Lawrence Source Type: news

Takeda profits hit as cancer drug loses market protection
Fears over sales of Velcade support case for £46bn deal to buy Shire (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - July 31, 2018 Category: Pharmaceuticals Source Type: news

Takeda Sees Lower Annual Profit, Generics to Erode Cancer Drug Sales Takeda Sees Lower Annual Profit, Generics to Erode Cancer Drug Sales
Japan's Takeda Pharmaceutical Co Ltd on Monday forecast a 17 percent drop in operating profit for the year through March 2019 as blood cancer drug Velcade (bortezomib) looks set to face generic competition in the United States.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 15, 2018 Category: Consumer Health News Tags: Pharmacist News Source Type: news

Maintenance Bortezomib: No Improved Depth of Response in “Plateaued” MM
Investigators concluded further investigations are warranted in elderly patients with either stable or responsive disease after bortezomib induction therapy. (Source: CancerNetwork)
Source: CancerNetwork - May 8, 2018 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Immuno Oncology Multiple Myeloma News Source Type: news

Maintenance Bortezomib: No Improved Depth of Reponse in “Plateaued” MM
Investigators concluded further investigations are warranted in elderly patients with either stable or responsive disease after bortezomib induction therapy. (Source: CancerNetwork)
Source: CancerNetwork - May 8, 2018 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Immuno Oncology Multiple Myeloma News Source Type: news

Janssen Announces Darzalex (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible
HORSHAM, PA, May 7, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with Velcade (bortezomib)*, a proteasome... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 7, 2018 Category: Drugs & Pharmacology Source Type: news

Bortezomib-induced Neuropathic Pain a Consequence of Sphingolipid-metabolism Dysregulation Bortezomib-induced Neuropathic Pain a Consequence of Sphingolipid-metabolism Dysregulation
Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 4, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

CytRx Corporation Names Eric L. Curtis as Its President and Chief Operating Officer
Seasoned Professional with 25 Years of Experience in Both Oncology and Orphan Diseases, Including Development and Commercialization of Approved Drugs Votrient, Doxil, Velcade and Benlysta LOS ANGELES, May 3, 2018 -- (Healthcare Sales & Marketing Network... Biopharmaceuticals, Oncology, Personnel CytRx, aldoxorubicin, soft tissue sarcoma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 3, 2018 Category: Pharmaceuticals Source Type: news

Multiple sclerosis drug could reduce painful side effects of common cancer treatment
(Rockefeller University Press) Researchers from the Saint Louis University School of Medicine have discovered why many multiple myeloma patients experience severe pain when treated with the anticancer drug bortezomib. The study, which will be published April 27 in the Journal of Experimental Medicine, suggests that a drug already approved to treat multiple sclerosis could mitigate this effect, allowing myeloma patients to successfully complete their treatment and relieving the pain of myeloma survivors. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - April 27, 2018 Category: Cancer & Oncology Source Type: news

Amgen Receives CHMP Positive Opinion To Add Updated Overall Survival Data To KYPROLIS ® (carfilzomib) Label
Label Variation to Include Overall Survival Data From Phase 3 ENDEAVOR Trial THOUSAND OAKS, Calif., Jan. 30, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a label variation for KYPROLIS® (carfilzomib) to include updated overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (KYPROLIS and dexamethasone [Kd] versus Velcade® [bortezomib] and dexamethasone [Vd]). The ENDEAVOR trial ...
Source: Amgen News Release - January 30, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves Addition Of Overall Survival Data To KYPROLIS ® (carfilzomib) Label
Phase 3 Data Showed KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent Versus Velcade® (Bortezomib) and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Overall Survival Results Support Use of KYPROLIS in Combination With Dexamethasone as New Standard of Care THOUSAND OAKS, Calif., Jan. 17, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS&re...
Source: Amgen News Release - January 17, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Bortezomib No Help for Kidney Transplant Rejection (CME/CE)
(MedPage Today) -- But researchers hold out hope that it could work in combo therapy (Source: MedPage Today Nephrology)
Source: MedPage Today Nephrology - December 14, 2017 Category: Urology & Nephrology Source Type: news

DARZALEX(R) (daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible
Phase 3 ALCYONE data showed DARZALEX in combination with bortezomib, melphalan and prednisone meaningfully improved progression-free survival and response rates Data featured as late-breaker at ASH 2017 (Abstract #LBA-4) and published in the New England... Biopharmaceuticals, Oncology Janssen Biotech, DARZALEX, daratumumab, multiple myeloma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 12, 2017 Category: Pharmaceuticals Source Type: news

Long-Term Analysis Of Phase 3 Head-To-Head Study Confirms KYPROLIS ® (Carfilzomib) Regimen Extends Overall Survival In Patients With Relapsed Multiple Myeloma
ENDEAVOR Study Long-Term Data Shows KYPROLIS and Dexamethasone Reduced the Risk of Death by 24 Percent Versus Velcade® (Bortezomib) and Dexamethasone Patients Treated With the KYPROLIS-Based Regimen Survived 9.0 Months Longer Than Patients Receiving Velcade and Dexamethasone Long-Term Follow-Up Demonstrated Consistent Safety Profile THOUSAND OAKS, Calif., Aug. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive results from a post-hoc analysis requested by the U.S. Food and Drug Administration (FDA) of the Phase 3 head-to-head ENDEAVOR trial, which followed patients for at least three y...
Source: Amgen News Release - August 30, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Accepts Amgen's Filing Of A Supplemental New Drug Application To Add Overall Survival Results To KYPROLIS ® (Carfilzomib) Label
FDA Sets PDUFA Target Action Date of April 30, 2018 THOUSAND OAKS, Calif., Aug. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) based on the overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that KYPROLIS® (carfilzomib) and dexamethasone (Kd) reduced the risk of death by 21 percent and increased OS by 7.6 months versus Velcade® (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (median OS 47.6 mon...
Source: Amgen News Release - August 30, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Overall Survival Analysis From KYPROLIS ® (carfilzomib) Phase 3 Endeavor Trial Published In The Lancet Oncology
KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent Compared to Velcade® (bortezomib) and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients KYPROLIS is the First and Only Multiple Myeloma Therapy Proven to Extend Overall Survival in a Head-to-Head Comparison With a Current Standard of Care in the Relapsed Setting THOUSAND OAKS, Calif., Aug. 23, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that results from an overall survival (OS) analysis of the Phase 3 head-to-head ENDEAVOR trial were published online first in The Lancet Oncology. Data showed that KYPROLIS® (...
Source: Amgen News Release - August 23, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Reduced Retreatment Dose Feasible in Relapsed, Refractory Multiple Myeloma
Prolonged use of bortezomib after treatment with combined bortezomib plus dexamethasone did not result in any significant benefit for patients with relapsed/refractory multiple myeloma compared with bortezomib plus dexamethasone alone, but this less dose-intensive approach could be a feasible option for patients who cannot tolerate the standard regimen. (Source: CancerNetwork)
Source: CancerNetwork - August 19, 2017 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Hematologic Malignancies Multiple Myeloma News Source Type: news

U.S. court upholds Takeda patent on cancer drug Velcade
(Reuters) - A U.S. appeals court ruled on Monday that a patent on Takeda Pharmaceutical Co Ltd's cancer treatment Velcade is valid, pushing back the date when generic drug makers including Teva Pharmaceutical Industries Ltd and Mylan NV will be allowed to launch lower-cost versions of the drug in the United States. (Source: Reuters: Health)
Source: Reuters: Health - July 17, 2017 Category: Consumer Health News Tags: healthNews Source Type: news