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Novartis' experimental cancer treatment wins endorsement of FDA advisers

14 July 2017

If the F.D.A. accepts the recommendation, which is likely, the treatment will be the first gene therapy ever to reach the market.

"The Leukemia & Lymphoma Society (LLS) applauds today's unanimous decision of the FDA advisory panel on Novartis' CAR-T immunotherapy, which marks a significant breakthrough for cancer patients", the LLS stated in a press release.

Key to Novartis' success was the high remission rate as well as 6-month and 12-month survival data for children and young adult patients who were running out of options.

"Tisagenlecleucel is an adoptive immunocellular cancer therapy that uses autologous peripheral blood T cells which have been reprogrammed with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and non-malignant cells", the FDA advisory panel report read.

Gaining approval for CTL019 could make it the first officially approved gene therapy in the United States.

The Food and Drug Administration advisory panel has voted in favor of this new gene treatment on which the members voted 10-0.

"When fully commercialized, this [CTL019] therapy will no doubt save the lives of many children and young adults who have had no other effective therapy for relapsed and refractory B-cell acute lymphoblastic leukemia [ALL]", said Dr. John Maris, a pediatric oncologist at The Children's Hospital of Philadelphia.

This revolutionary new method of treating blood cancer is customized to target a specific type of cancer, that is, it is adjusted according to the DNA information of a particular patient.

Novartis AG is now competing with Kite Pharma a developing medical field known as CAR-T, which involves immune cells being taken out and genetically modified to destroy cancer before it returns to the body, according to Bloomberg. "We believe that when this treatment is approved it will save thousands of children's lives around the world", Tom Whitehead, Emily's father, told the panel, according to The New York Times. These re-programmed cells then find and kill all the cancerous cells within the body.

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Twelve-year-old Emily Whitehead is the success story. The CAR-T space should start to heat up once other companies start to win FDA approval for their CAR-T therapies.

Tisagenlecleucel's benefit for ALL patients who have relapsed from other treatments was clear before the meeting.

Novartis is one of a handful of drugmakers, including Bellicom, Juno Therapeutics, and Kite Pharma, developing CAR-T therapies.

The treatment is the result of a joint effort between the University of Pennsylvania and pharmaceutical giant Novartis. He added that the treatment is "ushering in a new era".

The recommendation of ODAC was based on the evaluation of the CTL019 r/r B-cell ALL development program that included the firm-lead ELIANA study, which is claimed to be the first pediatric global CAR-T cell therapy registration trial.

David Maloney, medical director for cellular immunotherapy at Fred Hutchinson Cancer Research Center in Seattle, said he was elated that the field is moving forward.

"Even if there was disease that pops up later, the CAR-T cell could still eliminate it".

In May, Novartis signaled its interest in also developing allogeneic auto T-cell therapies, when it entered a nonexclusive license agreement with Celyad to use its USA patents to produce allogeneic vehicle T cells, in a deal that could generate up to $96 million in up-front and milestone payments for the Belgian biotech.

To prop up the patient's crippled immune system, an injection of immune-boosting immunoglobulin is needed every three to four weeks as long as the altered cells remain in the body, Novartis said in a statement.

Novartis' experimental cancer treatment wins endorsement of FDA advisers