Should the committee greenlight the immunotherapy, the FDA would likely take it up for a full approval in September. But the regulator is already sounding a note of caution saying that "postmarketing considerations for long-term safety monitoring may be necessary to address the potential safety concerns."
Novartis is well aware that the regulator is taking a wary look at CAR T therapy. The pharma giant plans on a muted introduction of the drug, relying on medical centers that are familiar with the treatment from its trials as well as focused training.
The FDA has approved a type of immunotherapy before, a type of drug known as checkpoint inhibitors for use in fighting solid tumors. In all, five different checkpoint inhibitors gained approval since 2011 for use against lung and bladder cancers as well as melanoma. Opdivo by Bristol-Myers Squibb Co. (BMY) and Keytruda from Merck & Co. (MRK) are two high-profile examples of checkpoint inhibitors.
But the immunotherapies that have been approved by the FDA are the same for each patient, unlike the CAR T therapy being considered by the FDA committee. But both types of immunotherapies act to amplify the body's ability to fight disease.
Kite Pharma Inc. (KITE) , a Santa Monica, Calif. biotech also has a CAR T therapy before the FDA to treat lymphoma but is a couple months out.
In an investor note Loncar said, "I predict that both Novartis and Kite will earn approval in the coming months, and this will be an inflection point for cellular therapies. This unique method of treating cancer is very special and has the potential to revolutionize the treatment of many cancers in the future."