Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • Medical Jobs
  • Medical Matrimony
  • MD Brand Connect
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • MCI News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Aborad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • MCI News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • Oncology
  • Oncology News
  • FDA approves cellular...

FDA approves cellular gene therapy for refractory multiple myeloma

Dr Satabdi SahaWritten by Dr Satabdi Saha Published On 2021-04-05T10:53:12+05:30  |  Updated On 5 April 2021 5:23 AM GMT
FDA approves cellular gene therapy for refractory multiple myeloma

In a recent development,FDA has given a nod to the first gene therapy for patients of relapsed or refractory multiple myeloma who have received at least four different previous therapies. FDA has further clarified that hospitals and their associated clinics that dispense ide-cel be specially certified and staff involved in the prescribing, dispensing or administering of ide-cel...

In a recent development,FDA has given a nod to the first gene therapy for patients of relapsed or refractory multiple myeloma who have received at least four different previous therapies. FDA has further clarified that hospitals and their associated clinics that dispense ide-cel be specially certified and staff involved in the prescribing, dispensing or administering of ide-cel be trained to recognize and manage CRS and nervous system toxicities and other AEs related to ide-cel.

Commercially marketed as idecabtagene vicleucel (ide-cel) (Abecma, Bristol Myers Squibb/bluebird bio), is a B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapy.

As for the study design, The trial evaluated 127 patients with relapsed or refractory multiple myeloma who had received at least three prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The efficacy-evaluable population consisted of 100 patients who received ide-cel within the dose range of 300 to 460 x 106 CAR-positive T cells. Of these patients, 88% received four or more prior lines of therapy and 85% were triple-class refractory.

Data analysis revealed the following facts.

  • The overall response rate for the efficacy-evaluable population was 72% (95% CI, 62%-81%), and 28% of patients achieved a stringent complete response (sCR) (95% CI, 19%-38%).
  • Responses were rapid and durable, with a median time to response of 30 days (range, 15-88 days).
  • Median duration of response was 11 months (95% CI, 10.3-11.4 months) for all responders and 19 months (95% CI, 11.4 months-NE) for those who achieved sCR. Of the 28 patients who achieved sCR, an estimated 65% (95% CI, 42%-81%) had remission lasting at least 12 months.
  • In patients treated with ide-cel in the KarMMa study, CRS and neurotoxicity were mostly of low grade and had early onset and resolution. CRS of any grade occurred in 108 patients (85%), grade 3 or higher CRS occurred in 12 patients (9%), and grade 5 occurred in one patient (0.8%). Neurotoxicity of any grade occurred in 36 patients (28%), including grade 3 or higher events in five patients (4%).

Primary source: Press releases from the FDA


multiple myeloma gene therapy FDA Approval 
Source : Press releases from the FDA
Dr Satabdi Saha
Dr Satabdi Saha

    Dr Satabdi Saha (BDS, MDS) is a practicing pediatric dentist with a keen interest in new medical researches and updates. She has completed her BDS from North Bengal Dental College ,Darjeeling. Then she went on to secure an ALL INDIA NEET PG rank and completed her MDS from the first dental college in the country – Dr R. Ahmed Dental College and Hospital. She is currently attached to The Marwari Relief Society Hospital as a consultant along with private practice of 2 years. She has published scientific papers in national and international journals. Her strong passion of sharing knowledge with the medical fraternity has motivated her to be a part of Medical Dialogues.

    Show Full Article
    Next Story
    Similar Posts
    NO DATA FOUND

    Editorial

    Journal Club Today

    Health News Today

    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok