Multiple Myeloma

Data from Phase III MAIA Study of Daratumumab Accepted for Presentation at Annual Meeting of American Society of Hematology

(P&T Community) Nov 20, 2018 - Genmab A/S announced today that data from the Phase III MAIA study of daratumumab in front line multiple myeloma, which was submitted by our collaboration partner Janssen Biotech, Inc., was accepted as a late-breaking abstract for oral presentation at the 60th Annual Meeting of the American Society of Hematology (ASH).

read article

CHMP Issues Positive Opinion on Split Dosing Regimen for DARZALEX® (daratumumab)

(Genmab) Nov 19, 2018 - CHMP issued positive opinion on split dosing regimen for DARZALEX; final decision from European Commission expected in the coming months; opinion supported by data from EQUULEUS (MMY1001) clinical trial.

read corporate press release

Seattle Genetics Initiates Phase 1 Clinical Trial of SEA-BCMA for Patients with Relapsed or Refractory Multiple Myeloma

(Morningstar) Nov 14, 2018 - Seattle Genetics, Inc. announced today dosing of the first patient in a phase 1 clinical trial evaluating the safety and tolerability of SEA-BCMA for patients with relapsed or refractory multiple myeloma (MM).

read article

Cellectar Announces FDA Grants Exemption to Import Alert for CLR 131 Hematology Studies

(NASDAQ) Nov 12, 2018 - Cellectar Biosciences, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted an exemption to the Import Alert placed on the Centre for Probe Development and Commercialization (CPDC), the sole supplier of the CLR 131.

read article

U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma

(Yahoo! Finance) Nov 6, 2018 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. In ELOQUENT-3, a randomized, open-label, Phase 2 trial, EPd demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival (PFS) and overall response rate (ORR) versus pomalidomide and dexamethasone (Pd).

read article

Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

(Karyopharm Therapeutics) Nov 7, 2018 – Karyopharm Therapeutics Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to selinexor, the Company’s first in class, oral SINE compound, for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy.

read corporate press release

FDA Approves Empliciti Regimen to Treat Relapsed or Refractory Myeloma

(Curetoday.com) Nov 6, 2018 - The Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, also known as EPd, for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor. The approval was based on the phase 2 ELOQUENT-3 trial, in which the addition of Empliciti to Pomalyst and dexamethasone reduced the risk of disease progression or death by 46 percent compared with Pomalyst and dexamethasone alone for patients with relapsed/refractory multiple myeloma.

read article

Thalidomide Reveals Path For Targeting “Undruggable” Transcription Factors For Cancer Treatment

(Broad Institute) Nov 2, 2018 - Researchers at the Broad Institute of MIT and Harvard, the Dana-Farber Cancer Institute, Brigham and Women's Hospital, and the University of Basel suggest that thalidomide and related drugs could provide a starting point for establishing a new class of cancer-fighting compounds.

read article

Amgen To Present New Data Showcasing Extensive Portfolio And Exciting Early Oncology Pipeline At ASH 2018

(Amgen) Nov 1, 2018 - Amgen today announced that new clinical data will be presented at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, Dec. 1-4, 2018. Data across an array of malignancies will be featured in 45 abstracts, including nine oral presentations, from the Company's broad portfolio and early-stage pipeline.

read corporate press release

Genmab Announces Positive Topline Results in Phase III MAIA Study of Daratumumab in Front Line Multiple Myeloma

(Genmab) Oct 29, 2018 – Genmab A/S announced today topline results from the Phase III MAIA study (MMY3008) of daratumumab in combination with lenalidomide and dexamethasone (DRd) versus Rd alone as treatment for newly diagnosed patients who are not candidates for high dose chemotherapy and autologous stem cell transplant (ASCT). The study met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.55 (95% CI 0.43 – 0.72), p < 0.0001) resulting in a 45% reduction in the risk of progression or death in patients treated with DRd. The median PFS for patients treated with daratumumab in combination with Rd has not been reached, compared to an estimated median PFS of 31.9 months for patients who received Rd alone.

read corporate press release

Celgene Keys In On ASH For Critical Look At Its Drugs Of The Future

(BioPharmaDive.com) Oct 25, 2018 - For December's ASH conference, Celgene execs said the following clinical trials will roll results out:

read article

REVLIMID® (lenalidomide) Demonstrated a Significant Improvement in Progression-Free Survival (PFS) Compared with Observation in a Randomized Study in Patients with Smoldering Multiple Myeloma

(Yahoo! Finance) Oct 23, 2018 - Celgene Corporation today announced results from an open-label phase II/III National Clinical Trials Network (NCTN) study led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. REVLIMID® (lenalidomide) was provided by Celgene under a clinical trials agreement with the NCI’s Division of Cancer Treatment and Diagnosis. ECOG E3A06 is a randomized study evaluating the safety and efficacy of the investigational use of REVLIMID monotherapy versus observation in patients with asymptomatic smoldering multiple myeloma.

read article

Genmab Announces Positive Topline Results in Phase III CASSIOPEIA Study of Daratumumab in Front Line Multiple Myeloma

(Genmab) Oct 21, 2018 - Phase III CASSIOPEIA study of daratumumab in combination with bortezomib, thalidomide and dexamethasone in front line multiple myeloma met the primary endpoint of stringent Complete Response (sCR) after induction and consolidation therapy.

read corporate press release

Mayo Clinic Researchers Identify Gene Types Driving Racial Disparities In Myeloma

(Mayo Clinic) Oct 10, 2018 - Researchers at Mayo Clinic have identified three specific gene types that account for a known two-to-three-fold increase in myeloma diagnoses among African-Americans.

read press release

U.S. Food and Drug Administration Accepts Karyopharm’s New Drug Application for Selinexor and Grants Priority Review

(Karyopharm Therapeutics) Oct 5, 2018 - Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) seeking accelerated approval for selinexor, its first in class, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma. The FDA also granted Karyopharm’s request for Priority Review and assigned an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA). In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application.

read corporate press release

Breakthrough Drug Shows Early Promise For Multiple Myeloma

(Imperial College London) Oct 8, 2018 - A small clinical trial has shown that a new drug has promise for targeting tumours in patients with an aggressive type of blood cancer.

read article

Myeloma Prescription Therapy Coverage Linked With Improved Outcomes in Medicare Beneficiaries

(Journal of Clinical Pathways) Oct 3, 2018 - Active prescription coverage for multiple myeloma immunomodulatory drugs through Medicare Part D is strongly associated with improved survival for patients with this disease, according to a report published in the Journal of Clinical Oncology (October 2018;36[28]:2879-2886).

read article

FDA Grants De Novo Designation for Adaptive Biotechnologies’ clonoSEQ Assay to Detect and Monitor Minimal Residual Disease (MRD) in Patients with Multiple Myeloma and Acute Lymphoblastic Leukemia

(MarketWatch) Sept 28, 2018 - Adaptive Biotechnologies [®] announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo designation for the clonoSEQ [® ] Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from a patient’s bone marrow sample. The clearance of clonoSEQ marks several “firsts” for patients and for the FDA. The clonoSEQ Assay represents a first-in-class MRD assay that uses next-generation sequencing (NGS) technology to assess disease burden, representing an important additional use of NGS in cancer. clonoSEQ is the first and only assay to be cleared by the FDA for MRD assessment in any lymphoid cancer and the first FDA-cleared diagnostic assay powered by immunosequencing.

read article

FDA Approves KYPROLIS® (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone (Kd70) For Patients With Relapsed Or Refractory Multiple Myeloma

(Markets Insider) Oct 1, 2018 - Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma. The approval is based on data from the Phase 3 A.R.R.O.W. trial, which demonstrated that KYPROLIS administered once-weekly at 70 mg/m2 with dexamethasone achieved superior progression-free survival (PFS) and overall response rates (ORR), with a comparable safety profile, versus twice-weekly KYPROLIS administered at a dose of 27 mg/m2 in combination with dexamethasone (twice-weekly Kd27). KYPROLIS is not approved for twice-weekly 27 mg/m2 administration in combination with dexamethasone alone.

read article

FDA Authorizes First Next Generation Sequencing-Based Test To Detect Very Low Levels Of Remaining Cancer Cells In Patients With Acute Lymphoblastic Leukemia Or Multiple Myeloma

(FDA.gov) Sept 28, 2018 - Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow. “At the FDA, we’re continuing to maximize opportunities for innovation that can improve patient outcomes,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s approval is an important step forward for patients suffering from ALL and multiple myeloma. Determining whether a patient has residual cancer cells remaining after treatment provides information on how well a patient has responded to therapy and how long remission may last.

read press release
Next Page