USFDA approves Cell Therapy for earlier lymphoma

The drug’s label warns of a serious complication associated with CAR-T therapy called cytokine release syndrome

166
USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 by The Health Master

The US Food and Drug Administration (USFDA) recently approved expanded use of Yescarta, a cell therapy made by Gilead Sciences Inc’s Kite unit, as the first option after chemotherapy for adults with an advanced, aggressive form of blood cancer.

The one-time treatment was initially approved in 2017 for patients with large B-cell lymphoma who did not respond to at least two previous rounds of therapy.

Yescarta is part of a class of treatments known as CAR-Ts, which involve taking immune system blood cells from a patient, shipping them to a plant to be re-engineered to better fight certain cancers and then returning them to the patient.

Kite’s trial results showed that Yescarta improved the length of time patients stayed alive without serious complications by 60 per cent over chemotherapy and stem cell transplant in second-line large B-cell lymphoma.

The National Comprehensive Cancer Network, the most influential source of US oncology treatment guidelines, has already listed Yescarta in the first category of treatments for those patients.

The USFDA said the drug’s label warns of a serious complication associated with CAR-T therapy called cytokine release syndrome, which can cause a range of dangerous symptoms, including fever and neurological problems.

USFDA approves Ozempic 2 mg to treat Type-II Diabetes

USFDA gives nod to Lupin for Sildenafil for oral suspension

USFDA gives approval to Glenmark Pharma for Lacosamide Tablets

USFDA approves drug for treatment of Seizures associated with rare disease

USFDA approves new Bristol Myers cancer Immunotherapy

USFDA approves first generic of Symbicort to treat Asthma and COPD

Drug Recall: IDArubicin Hydrochloride Injection recalled due to this reason

USFDA gives 13 observations to Lupin

Govt further extends timeline to apply for slots under PLI scheme

CDSCO panel gives nod to Roche for Anticancer Drug Entrectinib Capsules

Nutraceuticals Regulations 2022 to encourage Pharma Industry

NPPA notifies revised ceiling price for 872 dosage forms formulations

NDPS Act: Courts can’t declare a particular drug as ‘Manufactured Drug’ or ‘Psychotropic Substance’: High Court

Telangana to fill posts of 18 Drug Inspectors, 442 Pharmacists and 15 junior Analysts

NPPA updated price lists: Download

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news