The FDA will make a final decision on the drug by October 2017, according to Novartis spokesperson Julie Masow. <\/p>\n
The approval of the therapy is contingent upon Novartis' response to a number of issues, including chemistry, manufacturing, and safety questions. <\/p>\n
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. <\/p>\n
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. <\/p>\n
\"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. <\/p>\n
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What Families Need to Know About First Gene Therapy for Deadly Childhood Cancer - ConsumerReports.org<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" The FDA will make a final decision on the drug by October 2017, according to Novartis spokesperson Julie Masow. Continue reading