US FDA Mandates Label Updates On CAR-T Cancer Therapies

Washington: The U.S. Food and Drug Administration said on Thursday cancer therapies that use CAR-T technology will require changes to the so-called “boxed warning” to highlight the serious risk of T-cell blood cancer in patients who use these therapies.
The health regulor has required related updates to other sections of the label such as warnings and precautions, postmarketing experience, patient counseling information and medication guide.
The agency said patients and clinical trial participants receiving treatment with these products should be monitored life-long for secondary malignancies and the manufacturer should be notified in the event of a new malignancy.
In January, the FDA asked a host of drugmakers including Gilead Sciences Johnson & Johnson and Novartis to add a boxed warning to their CAR-T cancer therapies, as it received reports of patients developing a type of T-cell blood cancer after being treated with them.
The other cancer therapies include Bristol Myers Squibb’s Breyanzi and its therapy, Abecma, with partner 2seventy bio, J&J unit Janssen and Legend Biotech’s Carvykti, Novartis AG’s Kymriah, and Gilead unit Kite’s Tecartus and Yescarta.

Related Posts

  • Pharma
  • May 25, 2024
  • 65 views
NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of asthma inhaler drug combination formoteral 6 mcg and budesonide 400 mcg dry power inhaler (DPI) under…

  • Pharma
  • May 25, 2024
  • 75 views
Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Jaipur: To provide quality education in pharmacy institutes, the central government has prepared to end the duplicate system. Strict action will be taken against fake students and teachers in newly opened…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

A Doctor diagnoses Mood of Voters in Delhi

A Doctor diagnoses Mood of Voters in Delhi

NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Tripura Police Seized Banned Cough Syrup Worth Rs 30 Lakh In Dhalai; One Arrested

Tripura Police Seized Banned Cough Syrup Worth Rs 30 Lakh In Dhalai; One Arrested

Ex-Pharmacy Council Registrar Gave Certificates To Ineligible Candidates?

Ex-Pharmacy Council Registrar Gave Certificates To Ineligible Candidates?

Experts Call For Ethical Standards, Patient Advocacy In Clinical Research

Experts Call For Ethical Standards, Patient Advocacy In Clinical Research