FDA has just approved the first CAR-T therapy!

Truly a momentous day in the long and winding history of this life-saving therapy.  It’s initially approved for Acute Lymphoblastic Leukemia (ALL).  Can approval for Lymphoma be far behind?

Press Announcements > FDA approval brings first gene therapy to the United States

Novartis wins a landmark FDA approval with first CAR-T cancer drug

EP Vantage – World’s first CAR-T approval sweeps away more cell therapy doubts

Advertisements

Kite Seeks EU Approval for CAR T-Cell Therapy in 3 Lymphoma Subtypes (August 3, 2017)

Kite Pharma submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) requesting the approval of its CAR T-cell therapy, axicabtagene ciloleucel, as treatment for patients with certain lymphomas.

The include relapsed or refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL), who cannot receive autologous stem cell transplants.

This is the first application for a CAR T-cell therapy ever submitted to the EMA.

Full article: https://lymphomanewstoday.com/2017/08/03/kite-seeks-e-u-approval-car-t-cell-therapy-3-lymphoma-subtypes/

Support LLS, via a dear friend…

Not exactly "CAR-T news" per se, but…

A dear friend of ours, Laura Housley, was diagnosed with leukemia 17 years ago, and was saved by an allogeneic stem cell transplant (SCT).  In fact, she indirectly saved my life as well.  Almost five years ago, Laura recommended that I begin seeing the transplant specialist at the John Theurer Cancer Center of Hackensack Hospital.  It was he who in 2014 first recommended my enrollment in a CAR-T trial, over his own SCT treatment.  (I'd never even heard of CAR-T the first time he mentioned it.)  I owe Laura and him my life.

Since her recovery, Laura has gone on to do a lot of fundraising for The Leukemia & Lymphoma Society, and was nominated and named their Woman of the Year, for her role as a spokeswoman and fundraiser for the Society. She still offers support to patients about to undergo a SCT.  You can read her blog post for LLS here:

In November, Laura's daughter Sara, who is now in college, will be running for The Leukemia & Lymphoma Society's team, in the New York City Marathon.  If you're interested in donating, please see Sara's fundraising page:

(LLS is truly a worthy cause for present and future leukemia and lymphoma patients.  Donations to LLS contributed to CAR-T's development, and they have a very informative, helpful CAR-T page here.)

— Ben

SaraAndLaura_IMG_0843

LauraHousleyWomanOfTheYear

Kite Seeks EU Approval for CAR T-Cell Therapy in 3 Lymphoma Subtypes

Kite Seeks EU Approval for CAR T-Cell Therapy in 3 Lymphoma Subtypes

by Alice Melão

Kite Pharma submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) requesting the approval of its CAR T-cell therapy, axicabtagene ciloleucel, as treatment for patients with certain lymphomas.

The include relapsed or refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL), who cannot receive autologous stem cell transplants.

This is the first application for a CAR T-cell therapy ever submitted to the EMA.

“The MAA submission of axicabtagene ciloleucel marks an important global milestone in the development of engineered T-cell therapy,” Arie Belldegrun, MD, president and CEO of Kite, said in a press release.

He said the company is excited to be working with the EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) “to help bring this potentially transformative therapy to patients in the EU.”

Axicabtagene ciloleucel, formerly known as KTE-C19, is a CAR (chimeric antigen receptor) T-cell therapy. The treatment consist of collecting the patient’s own T-cells and modifying them to express a CAR protein that recognizes the surface protein CD19, a molecule that is widely expressed by B-cell lymphomas and leukemias.

Kite’s application includes primary data from the ZUMA-1 trial (NCT02348216), a Phase 1/2 trial testing axicabtagene ciloleucel in treatment-resistant or relapsed aggressive non-Hodgkin’s lymphoma patients. The trial included 101 patients with DLBCL, PMBCL, or TFL, most with advanced-stage disease.

Data presented late June at the 22nd Congress of the European Hematology Association (EHA), showed that 82 percent of patients responded to treatment after a single infusion of axicabtagene ciloleucel. This positive response was sustained in 44 percent of patients after a median follow-up time of 8.7 months. At that time, 39 percent of patients exhibited a complete response.

The most common severe treatment-related adverse events reported in ZUMA-1 included cytokine release syndrome and neurologic events, which were generally reversible after suitable management.

Axicabtagene ciloleucel has been designated a breakthrough therapy by the U.S. Food and Drug Administration for the treatment of DLBCL, TFL, and PMBCL, and received priority medicines (PRIME) regulatory support in the European Union. These designations are meant to support a drug’s development and accelerate its regulatory review.

The FDA is reviewing Kite’s biologics license application (BLA) submitted for axicabtagene ciloleucel for the treatment of refractory aggressive non-Hodgkin’s lymphoma. A final decision is expected by Nov. 29.