The FDA will make a final decision on the drug by October 2017, according to Novartis spokesperson Julie Masow.

The approval of the therapy is contingent upon Novartis' response to a number of issues, including chemistry, manufacturing, and safety questions.

CTLO19 was designated as a "breakthrough therapy" by the FDA back in 2014, which the agency grants to drugs that treat serious or life-threatening conditions and that demonstrate the potential to be significantly more effective than existing therapies.

But because of the complexity and novelty of the CTL019, says Masow, it will initially be offered at just 30 to 35 treatment centers in the U.S.

"This strategy will help ensure that each site is fully prepared with the necessary infrastructure in place to support the special ordering, cell collection, chain of identity, use, and site-level care associated with CTL019," Masow says.

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What Families Need to Know About First Gene Therapy for Deadly Childhood Cancer - ConsumerReports.org