Novartis AG (NYSE: NVS) announced Wednesday that the US Food and Drug Administration (FDA) has approved Kymriah (TM)(tisagenlecleucel) suspension for intravenous infusion, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Shares of Novartis increased in value about 14% year to date. The Approval wasn’t a surprise to investors, as the stock of Novartis lost about 1% Wednesday
Joseph Jimenez, CEO of Novartis, said in a statement, "Five years ago, we began collaborating with the University of Pennsylvania and invested in further developing and bringing what we believed would be a paradigm-changing immunocellular therapy to cancer patients in dire need. With the approval of Kymriah, we are once again delivering on our commitment to change the course of cancer care."
Kymriah is the first treatment that genetically engineers patients’ own blood cells to seek and destroy childhood leukemia (immunocellular therapy), according to the Washington Post. Other companies such as Juno Therapeutics Inc (NASDAQ: JUNO) are also working on similar treatments.
"This therapy is a significant step forward in individualized cancer treatment that may have a tremendous impact on patients' lives," said Carl June, MD, the Richard W. Vague Professor of Immunotherapy, Director of the Center for Cellular Immunotherapies in Penn's Perelman School of Medicine, who is a pioneer of this new treatment. "Through our collaboration with Novartis, we are creating the next wave of immunocellular cancer treatments, and are eager to progress CAR-T therapy in a host of hematologic and other cancer types."