Bortezomib

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

Onco360 Selected as the Preferred National Specialty Pharmacy Partner for XPOVIO® (selinexor)

Retrieved on: 
Wednesday, March 13, 2024
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Diagnosis, B-cell lymphoma, Dexamethasone, Selinexor, Partnership, Bortezomib, Patient, Carfilzomib, National Cancer Institute, Multiple myeloma, B cell, Lenalidomide, Daratumumab, Therapy, Bone marrow, Food, FDA, DLBCL, Follicular lymphoma, Pharmaceutical industry

Onco360®, the nation’s largest independent Oncology Pharmacy, is now the national specialty pharmacy network partner for Karyopharm’s product XPOVIO® (selinexor), a first-in-class, XPO-1 inhibitor.

Key Points: 
  • Onco360®, the nation’s largest independent Oncology Pharmacy, is now the national specialty pharmacy network partner for Karyopharm’s product XPOVIO® (selinexor), a first-in-class, XPO-1 inhibitor.
  • “Onco360 is excited to expand our partnership with the team at Karyopharm and become the preferred national specialty pharmacy partner for XPOVIO,” said Benito Fernandez, Chief Commercial Officer.
  • Multiple myeloma is an incurable hematological malignancy involving plasma cells.
  • Only 50 percent of patients diagnosed with multiple myeloma survive past five years following initial diagnosis.

U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma

Retrieved on: 
Friday, March 15, 2024
Dexamethasone, Type, Health, Survival, Multiple myeloma, Disease, Bortezomib, Oncology, Patient, Committee, EMA, Lenalidomide, European Medicines Agency, Daratumumab, DPD, Society, Johnson & Johnson, ODAC, Safety, ASCO, Food, Hematology, FDA, CHMP, Immunomodulatory imide drug, PVD, Annual general meeting, PDUFA, Pharmaceutical industry

RARITAN, N.J., March 15, 2024  /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of CARVYKTI® (11 to 0) finding the risk-benefit assessment of CARVYKTI® for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) date of April 5, 2024. 

Key Points: 
  • "We are pleased with the advisory committee's support for CARVYKTI in earlier lines of treatment based on the CARTITUDE-4 data," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • "As a physician and researcher committed to advancing patient care, the potential of CARVYKTI in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma."
  • The ODAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases.
  • The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA.

Starton Therapeutics Announces Opening of Second Clinical Site for STAR-LLD Phase 1b Trial in Multiple Myeloma and Provides Study Update

Retrieved on: 
Wednesday, February 14, 2024
Investigational New Drug, Peripheral edema, Anemia, Gastroenteritis, Medicine, Periodic breathing, Leukopenia, Diarrhea, Quality of life, Cough, Dizziness, Deep vein thrombosis, Nausea, Vomiting, DVT, Common, Tremor, Back pain, Constipation, Safety, Dexamethasone, First grade, Lower respiratory tract infection, URTI, Bronchitis, Therapy, Fatigue, Bortezomib, Pharmacokinetics, Thrombocytopenia, Rash, Patient, Neutropenia, Acceleration, Multiple myeloma, RMOC, IND, Insomnia, Lenalidomide, Appetite, Abdominal pain, Weakness, Pharmaceutical industry

The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®).

Key Points: 
  • The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®).
  • Remarkably, the trial is progressing ahead of schedule and with the addition of RMOC is now projected to conclude enrollment by Q1/2024.
  • I’m excited about the potential opportunity STAR-LLD can bring to multiple myeloma patients.”
    Earlier last month, Starton disclosed preliminary trial findings regarding the safety and efficacy of STAR-LLD for multiple myeloma.
  • Notably, no hematologic toxicities greater than Grade 1 have been observed following up to 3 cycles of treatment thus far.

L-Nutra Unveils Groundbreaking Study on Fasting Mimicking Diets (FMDs) and Chronic Lymphocytic Leukemia

Retrieved on: 
Tuesday, February 13, 2024
Breast cancer, Quality of life, CLL, FMD, Food, Chronic lymphocytic leukemia, Bortezomib, Leukemia, Patient, Fasting, Carfilzomib, Medicine, Research, Mouse, Pharmaceutical industry

CLL is the most prevalent form of leukemia in Western countries, and this groundbreaking research suggests a promising avenue for more effective treatment options.

Key Points: 
  • CLL is the most prevalent form of leukemia in Western countries, and this groundbreaking research suggests a promising avenue for more effective treatment options.
  • The study focused on the synergistic effects of cyclic fasting combined with proteasome inhibitors, experimental medication showing early promise for the treatment of CLL.
  • This suggests a potential benefit of fasting mimicking diets (FMDs) in treatment of milder CLL cases even without additional interventions.
  • The findings from this study open up potential new possibilities for CLL treatment strategies and food as medicine in general.

Orphan designation: bortezomib Treatment of patients with light chain (AL) amyloidosis, 08/11/2023 Positive

Retrieved on: 
Sunday, February 4, 2024
COMP, IRIS, Patient, EMA, European Commission, Amyloidosis, Bortezomib, Treatment, Committee, Pharmaceutical industry

Key facts

Key Points: 
  • Key facts
    - Active substance
    - bortezomib
    - Intended use
    - Treatment of patients with light chain (AL) amyloidosis
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2848
    - Date of designation
    - Sponsor
    Accord Healthcare S.L.U.
  • Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Starton Therapeutics Announces Initial Key Safety and Efficacy Signals with STAR-LLD in Patients with Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Wednesday, January 3, 2024
Quality of life, Leukopenia, URTI, Constipation, Lower respiratory tract infection, IND, Insomnia, CD8, Diarrhea, PD-1, DVT, Anemia, Gastroenteritis, Tremor, Fatigue, Common, CD4, Nausea, Multiple myeloma, Neutropenia, Abdominal pain, Therapy, Lenalidomide, Pharmacokinetics, Weakness, Dizziness, Thrombocytopenia, Cytotoxic T cell, Dexamethasone, Appetite, Periodic breathing, Bortezomib, Toxicity, Back pain, Patient, Safety, Peripheral edema, Deep vein thrombosis, Vomiting, Cough, Rash, Bronchitis

Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date. Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks. In comparison, adverse events in these patients observed during a prior regimen containing Revlimid® included nausea, vomiting, deep vein thrombosis (DVT), upper respiratory tract infections (URTI), anemia, and fatigue. None of the more common side effects of lenalidomide (Revlimid®), which include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor, have been observed with STAR-LLD. Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects. These data suggest that STAR-LLD may prove to be superior in tolerability to oral Revlimid, expanding the number of patients that get the full Revlimid® benefit and improving quality of life.

Key Points: 
  • Patient acceptance of self-administration using the ambulatory pump for lenalidomide delivery has been confirmed in this study.
  • Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date.
  • Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks.
  • Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects.

Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Physician, ATC, EMA, International, Multiple myeloma, Civil service commission, Lenalidomide, Dexamethasone, Bortezomib, Medication package insert, Committee, Patient, Anatomy, Medicine, CHMP, Generic drug

Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.

Key Points: 
  • Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.
  • Pomalidomide Viatris is a generic of Imnovid, which has been authorised in the EU since 05 August 2013.
  • Studies have demonstrated the satisfactory quality of Pomalidomide Viatris and its bioequivalence to the reference product Imnovid.
  • Treatment with Pomalidomide Viatris should be carried out under the supervision of physicians experienced in the treatment of multiple myeloma.

Nexcella Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023

Retrieved on: 
Monday, December 11, 2023
Patient, Bone marrow, MGUS, Cyclophosphamide, IND, Prevalence, Disease, NYHA, BCMA, MD, Daratumumab, Society, Standard of care, AL amyloidosis, ASH, Dexamethasone, LOS, Bortezomib, Hematopoietic stem cell transplantation, Treatment, CRS, Heart failure, Pharmaceutical industry

“We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient.”

Key Points: 
  • “We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient.”
    “We believe NXC-201 is the first and only CAR-T in clinical development for AL amyloidosis.
  • With our recent IND clearance, we are thrilled to be now activating sites to bring this first-of-a-kind study to U.S. relapsed/refractory AL Amyloidosis patients,” said Ilya Rachman, M.D., Ph.D., Executive Chairman of Nexcella.
  • Patients were infused with CAR+T cells at doses of 150 x 106 (n=1), 450 x 106 (n=2), and 800 x 106 (n=7).
  • MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril-Novel Diagnostics to Treatments for Amyloidosis

Immix Biopharma Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023

Retrieved on: 
Monday, December 11, 2023
Patient, Bone marrow, MGUS, Cyclophosphamide, IND, Prevalence, Disease, NYHA, BCMA, MD, Daratumumab, Society, Standard of care, AL amyloidosis, ASH, Dexamethasone, LOS, Bortezomib, Hematopoietic stem cell transplantation, Treatment, CRS, Heart failure, Pharmaceutical industry

LOS ANGELES, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced new clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis (R/R ALA) at an oral presentation by study investigator Moshe E. Gatt, MD at the 65th American Society of Hematology (ASH) Meeting being held in San Diego, CA. The updated results include follow-up and clinical data from one new patient. All patients were relapsed/refractory to standard-of-care Dara-CyBorD (daratumumab combined with cyclophosphamide, bortezomib, and dexamethasone) and had experienced a median of 6 prior lines of therapy that failed to stop worsening of disease prior to receiving NXC-201.

Key Points: 
  • “We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient.”
    “We believe NXC-201 is the first and only CAR-T in clinical development for AL amyloidosis.
  • With our recent IND clearance, we are thrilled to be now activating sites to bring this first-of-a-kind study to U.S. relapsed/refractory AL Amyloidosis patients,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma.
  • Patients were infused with CAR+T cells at doses of 150 x 106 (n=1), 450 x 106 (n=2), and 800 x 106 (n=7).
  • MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril-Novel Diagnostics to Treatments for Amyloidosis