ODAC

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.

FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy

Retrieved on: 
Friday, March 15, 2024
Biotechnology, FDA, Pharmaceutical, Health, Emory University, Multiple myeloma, BMY, Development, Survival, ASH, Disease, Oncology, Patient, FACP, Committee, EMA, Cell therapy, Bristol Myers Squibb, MD, Winship Cancer Institute, European Medicines Agency, Society, ODAC, CHMP, Food, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival.
  • The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application (sBLA) for Abecma for this patient population.
  • The FDA has not yet assigned a new target action date for review of the sBLA.
  • “With patients becoming triple-class exposed earlier in the multiple myeloma treatment paradigm, it is critical that new treatment options with the potential to improve long-term outcomes are available as early as possible,” said Sagar Lonial, MD, FACP, professor and chair, Department of Hematology & Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University.

Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS

Retrieved on: 
Thursday, March 14, 2024
Research, Hospitals, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Bone marrow, Patient, Transfusion-dependent anemia, Corporation, Imetelstat, ODAC, Anemia, Geron Corporation, MDS, Food, Medicine, Pharmaceutical industry

“We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS.

Key Points: 
  • “We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS.
  • Additionally, a sustained increase in mean hemoglobin levels in imetelstat-treated patients was observed over time compared to placebo patients.
  • The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, patients and caregivers, though the recommendations are not binding.
  • Geron plans to commercially launch imetelstat in the U.S. upon potential FDA approval.

Legend Biotech Reports Fourth Quarter and Full Year 2023 Results and Recent Highlights

Retrieved on: 
Monday, March 11, 2024
Research, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Johnson & Johnson, Growth, Drug discovery, Exercise, Partnership, Webcast, Patient, Committee, Collaboration, Nature, Senior, Lenalidomide, Investment, Investigational New Drug, Delta, ODAC, Janssen, CHMP, Food

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its fourth quarter and full year 2023 unaudited financial results and key corporate highlights.

Key Points: 
  • Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its fourth quarter and full year 2023 unaudited financial results and key corporate highlights.
  • Financial Results for Quarter and Year Ended December 31, 2023
    As of December 31, 2023, Legend Biotech had approximately $1.3 billion of cash and cash equivalents, time deposits, and short-term investments.
  • There was no license revenue for the three months ended December 31, 2023, and December 31, 2022.
  • License revenue for the year ended December 31, 2023, was $35.2 million, compared to $50.0 million for the year ended December 31, 2022.

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 and 2seventy bio Share Update on U.S. FDA Oncologic Drugs Advisory Committee Meeting for Abecma in Triple-Class Exposed Multiple Myeloma Based on KarMMa-3 Study

Retrieved on: 
Monday, February 5, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, ODAC, Federal, OS, Register, CHMP, Bristol Myers Squibb, PFS, Patient, EMA, BMY, Food, Society, Idecabtagene vicleucel, European Medicines Agency, ASH, Committee, Pharmaceutical industry

The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival (OS) from the study.

Key Points: 
  • The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival (OS) from the study.
  • Final PFS data and interim OS data from the KarMMa-3 study were presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition in December 2023.
  • Abecma also received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for patients with triple-class exposed relapsed and refractory multiple myeloma after at least two prior therapies.
  • Regulatory applications for Abecma for this patient population remain under review with the EMA and Swissmedic.

2seventy bio Announces New Strategic Path Forward

Retrieved on: 
Tuesday, January 30, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Partnership, ODAC, Multiple myeloma, Growth, Bristol Myers Squibb, CMO, Science, Research, Trial of the century, GV (company), Patient, AML, BMS, BCMA, LVV, Ovarian cancer, MUC16, Physician, Autoimmunity, APA, TS, PDUFA, Webcast, Workforce, Johnson & Johnson, Management

2seventy bio, in partnership with Bristol Myers Squibb (BMS), is taking actions to return Abecma to commercial growth in 2024.

Key Points: 
  • 2seventy bio, in partnership with Bristol Myers Squibb (BMS), is taking actions to return Abecma to commercial growth in 2024.
  • 2seventy bio and BMS are expanding its Abecma site footprint to enable more patients to access the treatment.
  • Upon closing of the transaction with Regeneron, Chip Baird, chief operating officer, will become chief executive officer of 2seventy bio.
  • After 13 years of service on the bluebird bio and 2seventy bio Board of Directors, Dan Lynch will step down from the Board in June and will continue in an advisory role for 2seventy bio.

Panbela Provides Business Update and Reports Q3 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
Pancreatic cancer, MSN, Acquisition, Safety, Oncology Drug Advisory Committee, Therapy, Castration, Data monitoring committee, Exercise, Clinical trial, Sanofi, Patient, DSMB, Intellectual property, Research, ODAC, Patent, DFMO, Doctor of Philosophy, CPP, PBLA, Eflornithine, Pharmaceutical industry

MINNEAPOLIS, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended September 30, 2023.

Key Points: 
  • MINNEAPOLIS, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended September 30, 2023.
  • The independent Data Safety Monitoring Board (DSMB) of the ASPIRE trial completed its pre-specified review of safety data for treated patients in the trial.
  • The aggregate gross proceeds from the exercise of the existing warrants totaled approximately $1.9 million, before deducting financial advisory fees.
  • Third Quarter ended September 30, 2023 Financial Results
    General and administrative expenses were $1.1 million in the third quarter of 2023, compared to $1.3 million in the third quarter of 2022.

Bristol Myers Squibb and 2seventy bio Provide Update on U.S. FDA Review of sBLA for Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Monday, November 20, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Oncology Drug Advisory Committee, NYSE, Safety, Food, European Medicines Agency, Progression-free survival, ASH, Risk, Patient, PFS, BMY, ODAC, Exposition, Death, RRMM, Society, PDUFA, OS, HIV disease progression rates, Pharmaceutical industry, Swissmedic, Idecabtagene vicleucel

The date of the ODAC meeting has not yet been confirmed by the FDA.

Key Points: 
  • The date of the ODAC meeting has not yet been confirmed by the FDA.
  • The FDA also informed the companies that a decision on the application will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.
  • The companies anticipate that the committee will review data related to the secondary endpoint of overall survival (OS).
  • The ODAC meeting has no impact on the currently approved indication for Abecma for adult patients with triple-class exposed RRMM after four or more prior lines of therapy.

Ajax Therapeutics Appoints Dr. David Steensma as Chief Medical Officer

Retrieved on: 
Wednesday, August 23, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Ruxolitinib, Novartis Institute for Tropical Diseases, Mayo Clinic, University, Oncology Drug Advisory Committee, Journal of Clinical Oncology, JAK, Type 2, Bone marrow, FACP, ODAC, Multimedia, Biomedical Research, Computational chemistry, Dana–Farber Cancer Institute, MDS, Harvard Medical School, Pancreatic serous cystadenoma, Bone marrow failure, Journal, Ajax, MD, Translational research, American Society of Hematology, Patient, Division, Edward, Memorial Sloan Kettering Cancer Center, Clinical professor, Research, FDA, Therapy, Malignancy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Food, Myelodysplastic syndrome, Disease, Pharmaceutical industry, Nursing, Hematology, Leukemia

Ajax Therapeutics, Inc., a biopharmaceutical company applying computational chemistry and structure-based technologies to develop next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced the appointment of David P. Steensma, MD, FACP, as Chief Medical Officer.

Key Points: 
  • Ajax Therapeutics, Inc., a biopharmaceutical company applying computational chemistry and structure-based technologies to develop next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced the appointment of David P. Steensma, MD, FACP, as Chief Medical Officer.
  • View the full release here: https://www.businesswire.com/news/home/20230823046723/en/
    Ajax Therapeutics CMO David Steensma, MD, FACP (Photo: Business Wire)
    “We are very fortunate to have such a veteran hematology drug developer as David join the Ajax team as we near the clinic with our next generation Type II JAK2 inhibitor program for MPNs,” said Martin Vogelbaum, CEO of Ajax Therapeutics.
  • Dr. Steensma has published over 200 original research papers as well as numerous reviews, editorials and book chapters.
  • He received his medical degree from the University of Chicago’s Pritzker School of Medicine.