For Indian patients with blood cancer who are at an advanced or relapsed stage of the disease, a “living drug” has been licensed. Patients with B-cell Non-Hodgkin Lymphoma (B-NHL) can now receive Qartemi, a CAR-T cell therapy, thanks to Immuneel Therapeutics, a biotech business based in Bengaluru.
After the Central Drugs Standard Control Organization (CDSCO) authorized the indigenous NexCAR19, created by ImmunoAct, a business based at the Indian Institute of Technology Bombay (IITB) and Tata Memorial Hospital, the medication is the second CAR-T cell therapy to be approved in India.
A “living drug” differs from a conventional chemical medicine in that it is derived from cells and has a sustained immunological response. These medications are cell therapy, which involves taking the patient’s cells, altering them, and then reintroducing them. This form of immunotherapy, known as CAR-T cell treatment, genetically modifies the patient’s T cells to target cancer cells.
For adult patients with relapsed or refractory B-NHL, Qartemi, a customized Chimeric Antigen Receptor or CAR-T cell, is now accessible locally.
With almost 1,20,000 new cases and more than 70,000 fatalities from leukaemia, lymphoma, and multiple myeloma each year, India is seeing an increasing burden of blood malignancies. In this way, Qartemi gives patients hope when traditional treatments, such as chemotherapy, do not work.
The drug’s developer is a gene and cell therapy venture supported by author and oncologist Dr. Siddhartha Mukherjee and Biocon founder Kiran Mazumdar Shaw.
“We are happy to develop this medication in-house at our facilities in Bangalore to ensure world standards of safety and efficacy by offering Qartemi at a significantly accessible price compared to global alternatives,” Immuneel Therapeutics CEO Amit Mookim said in a statement.
The cost of the therapy during treatment ranges from Rs 35 lakhs to Rs 50 lakhs, which the company claims is much less expensive than comparable international options.
Qartemi, which is intended for patients with relapsed or refractory B-cell malignancies, was the focus of the company’s 2022 CAR T-cell therapy trials. Because these individuals received little treatment when they relapsed or were in a refractory (drug-resistant) stage.
The IMAGINE trials were carried out at three prestigious medical facilities: PGIMER in Chandigarh, Apollo Cancer Hospital in Chennai, and Narayana Hospital in Bengaluru.
According to the IMAGINE trial’s findings, Qartemi was just as safe and effective as CAR-T cell treatments that have received FDA approval in the US. Through its Biotechnology Industry Partnership Programme (BIPP) program, the Department of Biotechnology’s Agency, BIRAC, provided support for the phase 2 clinical studies.
The drug’s total response rate in the Phase 2 trial was 83.3%. In order to provide Qartemi to its patients, the company has partnered with a number of hospitals, including Apollo Hospitals, CMC Vellore & Ludhiana, Manipal Hospitals, RGCIRC Delhi, SGPGI Lucknow, Amrita Hospital Faridabad, HOC Vedanta Ahmedabad, Cytecare Bangalore, Sparsh Bangalore, and Marengo Asia Hospitals, among others.
Qartemi, dubbed “India’s first international CAR T-cell therapy,” is licensed from Hospital Clinic de Barcelona (HCB), a world-renowned organization at the forefront of innovative cell therapy.
-NSH Digidesk
