YESCARTA (axicabtagene ciloleucel)

Approval of extension of indication to include use of Yescarta in adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

The variation updates the product information extensively as follows:

• SmPC updates to sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.1. 6.3 , 6.4, and 6.6
• Consequential updates to the Package Leaflet sections 1, 2, 3, 4, and 5

Update so that CAR-T cell-based therapies can be used in the EU/EEA also during confirmed tocilizumab shortages by treating physicians who consider that alternative suitable treatments for CRS can be used and such treatments are made available to manage this adverse reaction associated with CAR-T cell-based therapies use.

Update so that CAR-T cell-based therapies can be used in the EU/EEA also during confirmed tocilizumab shortages by treating physicians who consider that alternative suitable treatments for CRS can be used and such treatments are made available to manage this adverse reaction associated with CAR-T cell-based therapies use.

Kite Pharma EU B.V., has a responsibility to inform Healthcare Professionals on important safety information related to its medicines:
• Axicabtagene ciloleucel 
• Autologous anti CD19 transduced CD3+ cells
To uphold this responsibility, Kite has taken the decision to combine the risk minimisation materials for both products.

The combined version of patient alert card includes updates for the introduction of language related to Autologous anti CD19 transduced CD3+ cells and inclusion of free text for HCP to write the name of product infused, product batch number.

Kite Pharma EU B.V., has a responsibility to inform Healthcare Professionals on important safety information related to its medicines:
• Axicabtagene ciloleucel 
• Autologous anti CD19 transduced CD3+ cells
To uphold this responsibility, Kite has taken the decision to combine the risk minimisation materials for both products.

The combined version of HCP Educational Guide includes the following updates:

• Introduction of language related to Autologous anti CD19 transduced CD3+ cells
• Removal of the use of the Glasgow Coma Score and replacing with the measure of cognition and level of consciousness for supportive care in the management of Grade 2 Neurologic adverse reaction. Inclusion of levetiracetam for supportive care for the management of grade 2 Neurologic adverse reaction.
• Removal of the 3-day taper of corticosteroids for Grades 2, 3 and 4 adverse reactions in the neurotoxicity and CRS management guidance to now simply “Taper of corticosteroids”. This is to allow health care providers to taper based on the individual needs of each patient. The removal of the number of days is based on clinical practice/experience with Yescarta and aligns with the neurotoxicity management guidance approved for Tecartus.
• Administration of dexamethasone for management of grade 3 and 4 neurotoxicity with concurrent CRS no longer needs to be concomitant to administration with first dose of tocilizumab.
• Addition of discontinuation of tocilizumab for the management of grade 2 CRS and grade 2 neurotoxicity with concurrent CRS if symptoms improve.
• Update section 5: Important points to consider before you administer Yescarta or Tecartus with the following texts:
o As a part of the qualification process, HCPs will be trained on the Risk Minimisation Materials; the treatment centre is responsible for ensuring training of appropriate personnel.
o The aim of the registry is to collect long-term data for Yescarta and Tecartus. Such data is important to further understand the benefit/risk for these products.
o The inclusion of data in the registry does not replace the obligation to spontaneously report adverse events through through Safety_FC@gilead.com or telephone +44 (0) 1223 897500.
• Update Section 7: Guidance on managing neurologic adverse reactions with the following texts:
o Most patients recovered from neurologic adverse reactions, with the exception of four patients that died of other causes prior to resolution of their neurologic adverse reactions
• Improvements in readability

Kite Pharma EU B.V., has a responsibility to inform Healthcare Professionals on important safety information related to its medicines:
• Axicabtagene ciloleucel 
• Autologous anti CD19 transduced CD3+ cells
To uphold this responsibility, Kite has taken the decision to combine the risk minimisation materials for both products.

The combined version of handling guide includes updates for the introduction of language related to Autologous anti CD19 transduced CD3+ cells.

• • Changes in important points to consider before you administer Yescarta 

These changes are made to facilitate the administration of Yescarta to seriously ill patients with r/r Non-Hodgkin lymphoma while having a single dose of tocilizumab per patient on site, and access to an additional dose within 8 hours of each previous dose.

• • Changes in the categories of CRS severity and management

These changes were made to provide flexibility to the HCP in the management of Grade 2 CRS.

• • Changes in the guidance on managing neurologic adverse reactions

These changes were made to add 3 new neurologic adverse reactions reported in clinical trials and a new neurologic adverse reaction reported in the post-marketing setting.

• • Changes in the reporting of adverse reactions

These changes were made to clarify and emphasize the importance of spontaneous reporting.

• • Changes in the guide to handling and method of administration

These changes were made to facilitate the administration of Yescarta while having a single dose per patient of tocilizumab on site, and access to an additional dose within 8 hours of each previous dose. Additional changes were made with regards to wording on GMO requirements.

• • Addition of the Sampling recommendations for secondary malignancies section

These changes were made to add recommendations for additional testing in case of secondary malignancy.

• • Change to the format to a Roll Fold format

The change in format was made to accommodate the addition of the new section on Sampling recommendations for secondary malignancies section.

Type IB -  Registration of TCF04 (Hoofddorp, NL) for Day 0 manufacturing and final product importation/batch release

Section 6 of the PIL was updated to include the new Kite Pharma EU B.V. manufacturing facility, TCF04 (Hoofddorp, The Netherlands) as an additional manufacturing site responsible for batch release.

Type IB -  Registration of TCF04 (Hoofddorp, NL) for Day 0 manufacturing and final product importation/batch release

Update to section Section 4.4 -  Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

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