Breakthrough Designation for Novartis T-Cell Therapy Against ALL

Novartis has announced that the US Food and Drug Administration has granted Breakthrough Therapy status to CTL019, an investigative agent for patients with relapsed or refractory acute lymphoblastic leukemia in children and adults.

CTL019 is chimeric antigen receptor therapy (CART). That means that it uses CAR technology to "reprogram a patient's own T cells" to hunt down cancer cells that expess a specific protein on the cell surface known as CD19.

Once reprogrammed, the T cells (which then are called CTL019) are administered back into the patient's blood. There, they multiply and bind to the targeted CD19 positive cells and kill them.

"This Breakthrough Therapy designation underscores the potential of CTL019 as a life-saving therapy for patients with relapsed/refractory ALL, who are in desperate need of new treatment options," said David Epstein, Division Head, Novartis Pharmaceuticals.

"Novartis welcomes increased dialogue with the FDA and a potentially expedited review to streamline the development of CTL019 and hopefully bring this promising therapy to patients as quickly as possible."

Safety and efficacy have not been established yet for this agent.

Source: Novartis

More Articles

More Articles

In non-Hodgkin's lymphoma, you have your B-cell lymphomas and you have your T-cell lymphomas.

Why B...

MALT lymphoma is a rare B-cell non-Hodgkin's lymphoma that typically runs an indolent or slow-growing clinical...

Mantle cell lymphoma (MCL) is a relatively rare B-cell subtype of non-Hodgkin'...

Mantle cell lymphoma (MCL) is just one of 50-60 known B-cell subtypes of...

Lymphomatous meningitis [LM], also known as leukemic meningitis, is an extremely serious peripheral cancer that attacks the tissue that covers the...

Since so many chemotherapy agents can affect a patient’s sex drive and fertility, thinking about these issues prior...

Secondary cancers are cancers that develop as a result of chemotherapy and/or...

One of the greatest fears of lymphoma survivors is that they’ll relapse and have to undergo treatment again. This fear is normal but awful to...

Over the years, various classification systems have been used to differentiate lymphoma types including the Rappaport Classification (used until...

If you are new to this website or are looking for guidance to a specific page, here is a list of links to articles that can help you. The "Main...

Often the one who makes the first diagnosis of Hodgkin's Lymphoma / Disease is the person affected. There are some...

Lymphedema is abnormal swelling due to the presence of excess lymphatic fluid within the tissues. This swelling occurs when the...

There are two types of cancer: benign and malignant. Benign cancers are the kind that don't spread and don't threaten one's life. Malignant...

Advances in the treatment of Hodgkin's lymphoma have resulted in remarkable survival rates, even for...