Immunomodulatory imide drug

U.S. FDA Approves Bristol Myers Squibb and 2seventy bio’s Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy

Retrieved on: 
Friday, April 5, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, BMY, Disease, Progression-free survival, Patient, Research, Multiple myeloma, Pi, Commercial, Bristol Myers Squibb, Cytokine release syndrome, Idecabtagene vicleucel, Multimedia, Immunotherapy, Immunomodulatory imide drug, Food, Pharmaceutical industry

This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy.

Key Points: 
  • This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy.
  • Abecma was recently approved in Japan, Switzerland and the European Union for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after two prior lines of therapy, making it the only CAR T cell therapy available globally for earlier lines of therapy for patients with triple-class exposed relapsed and/or refractory multiple myeloma.
  • Abecma is also currently approved in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy.
  • KarMMa-3 is the only Phase 3 trial to evaluate a CAR T cell therapy in a patient population consisting entirely of triple-class exposed relapsed and refractory multiple myeloma patients.

Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) Becomes First CAR T Cell Therapy Approved in the European Union in Earlier Lines for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

Retrieved on: 
Wednesday, March 20, 2024
Oncology, FDA, Health, General Health, Pharmaceutical, Biotechnology, Civil service commission, BMY, Progression-free survival, Patient, Multiple myeloma, Pi, Bristol Myers Squibb, Doctor of Philosophy, European, ODAC, European Commission, PFS, Immunotherapy, Immunomodulatory imide drug, Food, Pharmaceutical industry

Abecma is the first chimeric antigen receptor (CAR) T cell immunotherapy approved in the European Union (EU) for use in earlier lines of therapy for relapsed and refractory multiple myeloma.

Key Points: 
  • Abecma is the first chimeric antigen receptor (CAR) T cell immunotherapy approved in the European Union (EU) for use in earlier lines of therapy for relapsed and refractory multiple myeloma.
  • * In the EU, Abecma has maintained its Orphan Designation for the treatment of multiple myeloma.
  • With increased use of the three main classes of therapy as combination regimens, more patients are becoming triple-class exposed earlier in their treatment journey.
  • Abecma is also approved in the U.S. for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy and approved in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy.

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.

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

Retrieved on: 
Friday, January 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Death, Patient, Immunomodulatory imide drug, European, CHMP, Progression-free survival, Neurotoxicity, European Medicines Agency, Cytopenia, Civil service commission, European Commission, Society, EMA, Risk, Head, Cytokine release syndrome, CRS, Multiple myeloma, Food, PFS, FDA, ASH, Committee, BMY, Pharmaceutical industry

The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

Key Points: 
  • The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
  • “This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T cell therapy, Abecma, to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes,” said Anne Kerber, M.D., senior vice president and head, Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb.
  • Treatment with Abecma exhibited a well-established safety profile, with mostly low-grade and transient occurrences of cytokine release syndrome (CRS) and neurotoxicity.
  • In the EU, the EC delivers its final decision approximately two months following receipt of the CHMP opinion.

Molecular Templates, Inc. Reports Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
Monday, November 13, 2023
CD38, Malignancy, PD-L1, Immunomodulatory imide drug, Neck, Bristol Myers Squibb, Research, Head, Alveolar soft part sarcoma, HIV disease progression rates, Patient, Part, ETB (company), TME, Therapy, Immunoglobulin A, Cancer, Symantec Endpoint Protection, BCMA, CMV, CPS, Biology, Pharmaceutical industry, Nursing, Vaccine, Medical imaging, Engineered wood

The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.

Key Points: 
  • The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.
  • Revenues for the third quarter of 2023 were $6.8 million, compared to $4.2 million for the same period in 2022.
  • Total research and development expenses for the third quarter of 2023 were $7.6 million, compared with $22.0 million for the same period in 2022.
  • Total general and administrative expenses for the third quarter of 2023 were $4.3 million, compared with $5.9 million for the same period in 2022.

Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs

Retrieved on: 
Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Dexamethasone, ASH, CRS, Patient, Cell, Infection, Bortezomib, B-cell maturation antigen, GPRC5D, Carfilzomib, Therapy, Bristol Myers Squibb, ORR, Cancer, Diagnosis, Anemia, International Myeloma Foundation, CD3, Cytokine release syndrome, Haematopoietic system, Multiple myeloma, Immunomodulatory imide drug, Safety, Immune system, Incidence, Aes, DOR, Science, Hook effect, Public, Drug discovery, Society, Estate (law), Lenalidomide, Proteasome inhibitor, Thrombocytopenia, PFS, BMY, Daratumumab, Neutropenia, Partnership, Skin, Life, Mezi proudy, Research, NYSE, Disease, MRD, Translational Genomics Research Institute, TCE, Survival, BMS, BCMA, Biology, Pharmaceutical industry, Vaccine, Fine chemical, Cohort, RRMM

Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.
  • These data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.
  • While multiple myeloma remains a relentless disease, we continue to transform the multiple myeloma treatment paradigm by dramatically improving outcomes for every patient.
  • As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Sunday, December 10, 2023
Webcast, Multiple myeloma, Associate, Immunomodulatory imide drug, Safety, SAN, DNA, TSCM, Prodrug, Therapy, Gene, International, CRS, Tissue, Artificial intelligence, SCR, Cytogenetics, Patient, Conference call, Blood, Haemophilia, Conference, Graft-versus-host disease, ORR, TCE, Cancer, Transposase, Partnership, Roche, Malignancy, Antibody, Neurotoxicity, Kinetics, Haemophilia A, RRMM, Cyclophosphamide, BCMA, Physician, Investigator's brochure, Bone marrow, ITT, Vanderbilt-Ingram Cancer Center, Cytokine release syndrome, Vaccine, Pharmaceutical industry, Broadcasting, Hematology

The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results.
  • They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."
  • Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
    Session Title: 704.

ELREXFIO™ (elranatamab-bcmm), Now Available from Onco360

Retrieved on: 
Wednesday, September 13, 2023
FDA, Health, Pharmaceutical, Clinical Trials, Oncology, REMS, Cytokine release syndrome, Malignancy, US FDA, Mitigation, CD3, CRS, Multiple myeloma, Immunomodulatory imide drug, Cancer, Bone marrow, National Cancer Institute, Cohort study, Pharmacy, CAR, US, Specialty pharmacy, Patient, B cell, SEER, ADC, Diagnosis, RRMM, Caregiver, Phase, ORR, BCMA, Pfizer, Disease, Vaccine, Pharmaceutical industry, Epidemiology

Onco360®, the nation’s leading independent Specialty Pharmacy will be a pharmacy provider for Elrexfio™ (elranatamab-bcmm).

Key Points: 
  • Onco360®, the nation’s leading independent Specialty Pharmacy will be a pharmacy provider for Elrexfio™ (elranatamab-bcmm).
  • This indication is approved under accelerated approval based on response rate and durability of response.
  • Multiple myeloma, a rare malignancy, accounts for 1.8% of all new cancer cases in the United States.
  • The five-year overall survival (OS) for patients with multiple myeloma is 59.8%.3
    ELREXFIO is commercialized by Pfizer.

Molecular Templates, Inc. Reports Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, August 10, 2023
Intellectual property, PR, Therapy, PD, Symantec Endpoint Protection, Bank statement, Neoplasm, Immunomodulatory imide drug, Food, Aes, Food and Drug Administration, RECIST, MHC, Cancer, Bristol Myers Squibb, NSCLC, Immunoglobulin A, Bone disease, Sale, Monocyte, CD8, HIV disease progression rates, MDSC, PD-L1, Patient, CMV, TME, Biology, BMS, Private placement, FDA, ETB, Pembrolizumab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Partial-response maximum-likelihood, WalletHub, BCMA, Safety, Conference, Pharmaceutical industry, Nursing, Medical imaging, Security (finance), Vaccine, Medical device, Palladium

Revenues for the second quarter of 2023 were $6.9 million, compared to $4.4 million for the same period in 2022.

Key Points: 
  • Revenues for the second quarter of 2023 were $6.9 million, compared to $4.4 million for the same period in 2022.
  • Revenues for the second quarter of 2023 were comprised of revenues from collaborative research and development agreements with Bristol Myers Squibb and grant revenue from CPRIT.
  • Total research and development expenses for the second quarter of 2023 were $13.4 million, compared with $21.4 million for the same period in 2022.
  • Total general and administrative expenses for the second quarter of 2023 were $5.2 million, compared with $6.6 million for the same period in 2022.

NMPA and FDA Approved the First-in-Human Clinical Trial Applications to Evaluate LBL-034, An Anti-GPRC5D/CD3 Bispecific Antibody Developed by Leads Biolabs, in Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Monday, July 31, 2023
Life, Marketing, Multiple myeloma, Immunomodulatory imide drug, Cancer, Trial of the century, Creative Biolabs, Investigational New Drug, Patient, Risk, National Medical Products Administration, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, NMPA, Food, Safety, Pharmaceutical industry

This study aims to evaluate the safety and tolerability of LBL-034, determine the recommended Phase II dose and assess its efficacy in patients with multiple myeloma.

Key Points: 
  • This study aims to evaluate the safety and tolerability of LBL-034, determine the recommended Phase II dose and assess its efficacy in patients with multiple myeloma.
  • "Despite recent progress and continuous advancements in multiple myeloma, the time between recurrences has been steadily decreasing, particularly as the number of treatment lines increases.
  • This ultimately leads to emergence of relapsed or refractory multiple myeloma, reaffirming its status as an incurable malignant tumor that poses a serious threat to human life.
  • We adhere to our tradition of innovation and aim to deliver an important, novel and effective treatment option for patients with poor prognosis of relapsed/refractory multiple myeloma."