The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) approve Novartis’ CAR-T therapy Kymriah (tisagenlecleucel, formerly CTL019).

The blood cancer treatment gained FDA approval in August 2017 having initially been developed by researchers at the University of Pennsylvania. Following a recommendation from the CHMP, the CAR-T cell therapy will now be reviewed by the EMA for approval in the European Union.

The one time treatment, which uses a patient’s own T cells to fight cancer, received the positive opinion based on two pivotal Novartis-sponsored Phase II trials that included patients from Europe, the US, Australia, Canada and Japan.

The CHMP’s positive opinion covers two forms of aggressive malignancies: B-cell acute lymphoblastic leukaemia (ALL) and diffuse B-cell lymphoma (DLBCL), both of which suffer from significant treatment gaps in patients. While ALL accounts for approximately 80% of leukaemia cases among children in Europe, DLBCL is the most common form of non-Hodgkin lymphoma accounting for up to 40% of cases worldwide. If approved, the therapy will be the first CAR-T cell therapy available for both DLBCL and B-cell ALL in the European Union.

As stated by Liz Barrett, CEO of Novartis Oncology: "The positive CHMP opinion for Kymriah is a watershed moment for paediatric and adult patients in Europe with aggressive blood cancers. This truly transformative therapy helps address a profound unmet need, and Novartis is proud that our leadership in CAR-T innovation will make a meaningful difference to patients in the EU."     

The European Commission will now review the CHMP’s recommendation to deliver a final decision regarding the treatment’s approval, which would be applicable to all 28 EU member states plus Liechtenstein, Iceland and Norway.

"Today’s positive opinion from the CHMP marks a truly extraordinary moment for those who have been impacted by these types of advanced and aggressive B-cell malignancies," said Dr Ulrich Jäger, Professor of Hematology at the Medical University of Vienna and Head of Hematology at the General Hospital of the City of Vienna. "European patients and doctors have been anxiously awaiting the introduction of Kymriah, which will bring a significant advancement in the treatment landscape for these patients who face a poor prognosis."  

Additional regulatory filings are under review for Kymriah in Canada, Switzerland, Australia and Japan.

--------------------------------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of n-CPhI.Cn, 

welcome to send your CV and sample works to us, 

Email: Julia.Zhang@ubmsinoexpo.com.