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Novartis moves swiftly with lymphoma filing for CAR-T Kymriah

Will go up against Kite Pharma's Yescarta if approved


Just a few weeks after claiming the first approval for a CAR-T therapy, Novartis is trying to extend its lead by filing for a second indication.

Kymriah (tisagenlecleucel) became the first registered treatment that uses a patient's own T cells to fight cancer when it got a green light from the FDA in refractory B-cell precursor acute lymphoblastic leukaemia (ALL) in September. Now, Novartis wants to extend its use into relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common forms of non-Hodgkin’s lymphoma (NHL).

Approval for DLBCL will up the ante in Novartis’ rivalry with CAR-T developer Kite Pharma - now part of Gilead Sciences - which got the go-ahead from the US regulator for its Yescarta (axicabtagene ciloleucel) in relapsed/refractory B cell lymphoma earlier last week.

The filing is based on the results of the JULIET trial, which at the interim stage showed a 45% overall response rate after three months, including 37% complete responses, in patients whose lymphoma had progressed despite first-line therapy and were ineligible for an autologous stem cell transplant (ASCT) - the main second-line treatment for DLBCL. Novartis is planning to present additional data from the study at the American Society of Hematology meeting in Atlanta in December.

If approved, Kymriah will provide another treatment option for the roughly one third of DLBCL patients who don’t achieve and maintain complete remission after first-line treatment and - if they can’t have an ASCT - have a life expectancy of three to four months.

“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,” said Novartis’ chief medical officer and CEO-elect Vas Narasimhan.

Novartis said it plans to submit an additional marketing application for Kymriah with the EMA for both DLBCL and paediatric ALL later this year, and will follow that with regulatory filings outside the US and EU in 2018.

Article by
Phil Taylor

31st October 2017

From: Regulatory



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