Novartis Asks FDA to Approve Kymriah for Difficult-to-treat DLBCL

Novartis Asks FDA to Approve Kymriah for Difficult-to-treat DLBCL

Novartis has asked U.S. regulators to expand their approval of Kymriah (tisagenlecleucel) to include the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL.

The Food and Drug Administration approved  Kymriah — the first commercially available CAR T-cell therapy — for children and young adults with B-cell acute lymphoblastic leukemia only two months ago. A CAR T-cell therapy uses a patient’s own re-engineered immune cells to fight cancer. A relapsed cancer is one that has returned, and a refractory cancer one that has failed to respond to treatment.

Novartis’ new application asks the FDA to approve Kymriah for relapsing or refractory DLBCL patients who are not eligible for a stem cell transplant — a group that faces a 40 percent risk of death.

“Kymriah represents a historic breakthrough in the evolution of individualized immunotherapy, and we are committed to bringing this innovation to as many patients who may benefit as possible,” Vas Narasimhan, Novartis’ chief medical officer, said in a press release.

The company supported its application with results from the Phase 2 JULIET clinical trial (NCT02445248) that was collaboration between Novartis and University of Pennsylvania medical researchers. The study met its primary goal by eradicating cancer in 37 percent of patients treated with Kymriah.

Novartis will present six-month results of the trial at the American Society of Hematology Annual Meeting in Atlanta in December.

“The response rates we’ve seen in the JULIET trial show that Kymriah has the potential to transform treatment for these patients, and we look forward to collaborating with the FDA to make it available to patients for this second indication,” Narasimhan said.

While up to 60 percent of DLBCL patients get well after their first treatment, about a third relapse. In this group, only about one in four is eligible for a stem cell transplant, the standard second-line treatment.

Without another treatment, relapsed DLBCL patients have a dim chance of survival. In fact, their life expectancy is only three to four months.

“The approval of tisagenlecleucel in the treatment of children and young adults with second relapse or refractory B-cell ALL [acute lymphoblastic leukemia] was a watershed moment in the journey for researchers to develop immunocellular therapies,” said Dr. Stephen Schuster, director of the Lymphoma Program and Lymphoma Translational Research at the University of Pennsylvania’s Perelman School of Medicine.

“The data show this therapy could change the treatment paradigm for patients with r/r [relapsing or refractory] DLBCL, as we’ve seen durable complete responses in patients who previously relapsed or were refractory to prior therapies,” he added.

Novartis plans to ask the European Medicines Agency to authorize Kymriah as a treatment for both adults with DLBCL and children with acute lymphoblastic leukemia later this year.

“This second filing is a significant step toward realizing its potential for even more patients who are currently battling fatal blood cancers,” Schuster said.

The FDA approved another CAR T-cell therapy — Kite Pharma‘s Yescarta (axicabtagene ciloleucel) — in October as a treatment for relapsed or refractory large B-cell lymphoma.

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