Published: Fri, July 14, 2017
Medical | By Rita Mcdonald

Engineered cell therapy for cancer gets thumbs up from FDA advisers

Engineered cell therapy for cancer gets thumbs up from FDA advisers

"This is a major advance, and is ushering in a new era", said Malcolm Smith, a paediatric oncologist at the National Institutes of Health in Bethesda, Maryland.

Yesterday, the FDA's Oncologic Drugs Advisory Committee (ODAC) held a hearing to evaluate Novartis CTL019. These cells are then shipped to a Novartis laboratory for thawing and genetic tinkering. But they raised concerns about potentially life-threatening side effects-short-term worries about acute reactions, like those Emily experienced, and longer-term worries about whether the infused cells could, years later, cause secondary cancers or other problems.

A rendering of a T-cell that can be reprogrammed to attack cancer cells.

CTL019 is a lentivirally transduced CAR-T B cell therapy in which a patients B cells are isolated by cryopreserved leukapheresis, and genetically engineered to express a chimeric T cell receptor containing the CD19 B cell antigen linked to a co-stimulatory domain including the CD3zeta and 4-1BB proteins.

Variations in quality attributes, potency, and transduction efficiency of Novartis' biological cell therapy CTL019, however, did not translate into changed safety or efficacy, according to statistical analyses.

Sporadic clashes in Iraq's Mosul after victory declaration
He cited allegations of threats of collective punishment and forced evictions in Mosul by Iraqi security forces and their allies. The US-led coalition that backed the Mosul offensive is supporting another assault on ISIS's Syrian bastion Raqa.

Immunotherapy is a growing field in cancer treatment and medications that alter the body's immune system to fight cancer are already on the market. The extraction, genetic engineering, and re-infusion of a patient's own immune cells is a pathbreaking method of treatment now being explored by various pharmaceutical firms for the treatment of numerous cancers. Every few months they receive infusions of immune globulins.

If the FDA approves the approach, it would be limited to a small group - children and young adults under the age of 25 with B-cell acute lymphoblastic leukemia that have relapsed despite chemotherapy. That happens to more than 600 patients in the USA each year.

In a test conducted, gene therapy results exceeded chemotherapy, and even newer types of cancer medicines.

In preliminary results of the landmark ELIANA trial, which studied 50 children with ALL over six months, researchers reported that 82 percent of patients treated with CTL019 achieved complete remission -- meaning an eradication of cancer cells -- after three months.

Doctor Gwen Nichols, the chief medical officer of the Leukemia and Lymphoma Society, says the nest step is to discover "what we can combine it with and is there a way to use it in the future to treat patients with less disease, so that the immune system is in better shape and really able to fight".

Trump's Controversial State Visit to Britain Put Off till 2018
But he could still visit the United Kingdom in a less formal capacity before the end of the year, according to reports. However, there was no mention of in the Queen's Speech, and October was later mooted as a possible date.

"This is the beginning of something big", she added.

Developed by the University of Pennsylvania and Novartis Corp., the therapy could be the first of its kind - an innovative treatment custom-made to target specific forms of cancer, USA Today reports.

Hundreds were in attendance at the committee meeting, with both scientists and parents of children who underwent the treatment endorsing agency approval. She nearly died as a result of leukemia, which was considered fatal until she was treated at age 6. But many of those participants have remained cancer free for months or years. Although more than half of those with this diagnosis were children and teens, they represented only 14% of those who died that year.

CTL019 is a customized treatment made by harvesting patients' white blood cells and rewiring them to home in on tumors.

Listen to the Moment a Jet Avoided 'Greatest Aviation Disaster'
In December 2015, an Alaska Airlines Boeing 737 landed on a central taxiway at Seattle-Tacoma International Airport. Federal Aviation Administration and Air Canada will look at why the pilots made a mistaken approach anyway.

Like this: