Novartis wins speedy U.S. review of new leukemia drug

ZURICH (Reuters) - A new leukemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration (FDA), putting the Swiss drugmaker ahead of rivals working on similar cancer therapies.

FILE PHOTO: The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland, January 25, 2017. REUTERS/Arnd Wiegmann/File Photo

The FDA’s announcement late Wednesday means the regulator plans to take action within six months on Novartis’s so-called chimeric antigen receptor T cell therapy, or CAR-T, in partnership with University of Pennsylvania researchers.

The medicine, called CTL019, is a treatment for young patients with B-cell acute lymphoblastic leukemia.

Novartis shares were little changed on Thursday, but UK-based Oxford BioMedica, which makes ingredients for CTL019 and will reap undisclosed royalties from future sales, rose more than 4.5 percent on the announcement.

The therapy involves taking a patient’s own T-cells, altering them in the lab to help the immune system find and kill cancer cells, and then re-infusing them into the patient.

Basel-based Novartis is now in pole position with regulators as it pushes for approval alongside rivals including biotech Kite Pharma Inc that are developing similar therapies.

“With CTL019, Novartis is at the forefront of the science and development of immunocellular therapy as a potential new innovative approach to treating certain cancers where there are limited options,” Vas Narasimhan, Novartis head of drug development, said in a statement.

CTL019 will likely cost hundreds of thousands of dollars per patient if approved, and Novartis counts it among drugs it believes will eventually exceed $1 billion in annual sales.

Analysts do not expect significant sales to materialize quickly, however, due in part to the challenging process necessary to extract, re-engineer and re-infuse T cells for each patient.

This complexity is among factors that will “likely constrain commercial implications for CTL019 near term,” wrote Emmanuel Papadakis, a Barclays analyst who expects the therapy to win approval in the third quarter and to be launched in early 2018.

In a Phase II study, Novartis said 82 percent of patients infused with CAR-T cells achieved complete remission or complete remission with incomplete blood count recovery at three months after treatment. In December, Novartis estimated 60 percent of those responders were relapse-free after six months.

The company plans to submit an application for market authorization with the European Medicines Agency (EMA) later this year. It also plans eventually to seek approval for CTL019 to be used in patients with certain types of relapsed or refractory non-Hodgkin lymphoma, another type of blood cancer.

Reporting by John Miller; Editing by Mark Potter