A cancer treatment that one expert called the 'most exciting thing I’ve seen in my lifetime' just got closer to approval (NVS)

pulse

July 12, 2017 8:32 PM

By the end of the year, two companies' CAR-T cell therapies could be approved for different blood cancers.

Cancer cells are seen on a large screen connected to a microscope at the CeBit computer fair in Hanover, Germany, March, 6, 2012.

Novartis went before the FDA on Wednesday for an advisory committee meeting to present data for CTL019, a treatment for pediatric acute lymphoblastic lymphoblastic leukemia. The panel voted unanimously 10-0 in favor of recommending the treatment.

"I think this is most exciting thing I’ve seen in my lifetime," Dr. Tim Cripe, an oncologist who was on the panel said while explaining his vote.

The highly personalized treatment is called CAR T-cell therapy. It's a type of cancer immunotherapy — or a therapy that harnesses the body's immune system to take on cancer cells.

Short for chimeric antigen receptor T-cell therapy, CAR-T treatment takes a person's own cells, removes them from the body, re-engineers them, and then puts the cells back in the body where they can attack cancer cells. Novartis' therapy is one of two cutting-edge treatments for blood cancers are poised to get approved by the end of the year.

The company is expected to get a decision from the FDA by October, Bloomberg reported.

The following month, Kite Pharma, the other company in the race, is expected to get an answer from the FDA. That's for Kite's CAR-T treatment for aggressive B-cell non-Hodgkin lymphoma (more general than DLBCL). In data Kite released in February, the company found that out of the 101 patients, 36% had a complete response to the treatment after six months.

It's a type of cancer that Novartis wants to get approval for in the future. In June, Novartis released data from its Phase 2 trial of CTL019 in patients with diffuse large B-cell lymphoma (DLBCL for short), an aggressive form of lymphoma that's one of the two types Kite's data looks at. The trial found that of the 51 patients with DLBCL, 23 had either a complete response (meaning cancer had disappeared completely) or a partial response (meaning their tumor displayed signs that it was shrinking).

There are a few other challenges facing these new treatments: