Cell Therapy - CHMP Minutes for the Meeting on 27-30 March 2023

Type II variations – variation of therapeutic indication procedure according to Commission Regulation  (EC) No 1234/2008; Opinions or Requests for supplementary information

Breyanzi – lisocabtagene maraleucel / lisocabtagene maraleucel – Bristol-Myers Squibb Pharma EEIG

• “Extension of indication to include treatment of adult patients with Second-line (2L) Transplant Intended (TI) Large B-Cell Lymphoma (LBCL) for Breyanzi, based on interim analyses from pivotal study JCAR017-BCM-003; this is a global randomized multicentre Phase III Trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell NonHodgkin Lymphomas (TRANSFORM); As a consequence, sections 4.1, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The annex II and Package Leaflet is updated in accordance. The MAH also took the opportunity to implement editorial changes in line to the core SmPC. Version 2.4 of the RMP has also been submitted.”
• The CHMP was updated on discussions at CAT. The Committee confirmed that all issues previously identified in this application had been addressed.
• Based on the draft opinion prepared by the CAT, the CHMP adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.

CHMP-PRAC assessed procedures

MINJUVI - tafasitamab - Incyte Biosciences Distribution B.V.,

• “Update of section 4.4 of the SmPC in order to add a new warning on Progressive Multifocal Leukoencephalopathy (PML) based on postmarketing data; the Package Leaflet is updated Request for supplementary information adopted with a specific timetable. The RMP version 2.0 has also been submitted. In addition, the MAH took the opportunity to implement editorial changes in the SmPC and to bring the PI in line with the latest QRD template version 10.3.”
• Request for Supplementary Information adopted on 16.03.2023

Polivy - polatuzumab vedotin - Roche Registration GmbH,

• “To submit the updated final OS CSR for study GO39942 - A Phase III, multicenter, randomized, double-blind, placebocontrolled trial comparing the efficacy and safety of polatuzumab vedotin in combination with R-CHP versus R-CHOPin previously untreated patients with DLBCL (POLARIX) listed as a category 3 study in the RMP. This submission will address the missing information of "long-term safety" in patients treated with polatuzumab vedotin. An updated RMP version 4.0 has also been submitted to remove the commitment for this study along with the missing information of "long-term safety".”
• Positive Opinion adopted by consensus on 16.03.2023.

PRAC assessed procedures

Xospata - gilteritinib - Astellas Pharma Europe B.V.,

• “Submission of the final report from study 2215-PV-0001 - Evaluation of the effectiveness of the Xospata Routine Risk Minimisation Measures (RMMs) and an additional Risk Minimisation Measure (aRMM): A Cross sectional study among Healthcare Professionals to assess awareness and knowledge, listed as a category 3 study in the RMP. The RMP version 3.0 has also been submitted.”
• Request for Supplementary Information adopted on 16.03.2023 with a specific timetable.

CHMP-PRAC-CAT assessed procedures

Breyanzi - lisocabtagene maraleucel / lisocabtagene maraleucel -

Bristol-Myers Squibb Pharma EEIG,

• “Update of section 5.1 of the SmPC in order to update efficacy information based on final results from studies 017001 and JCAR-017- Request for supplementary information adopted with a specific timetable. BCM-001 listed as obligations in the Annex II. These studies aimed to further characterise the long-term efficacy and safety of Breyanzi in patients treated with relapsed or refractory DLBCL, PMBCL, FL3B after two or more lines of systemic therapy. Study 017001 is a phase 1, open-label, single-arm, multicohort, multicentre, seamless design trial, while study JCAR-017-BCM-001 is a phase 2, open-label, single-arm, multicohort, multicentre trial. The Annex II is updated accordingly. The RMP version 3.0 has also been submitted.”
• Request for Supplementary Information adopted on 24.03.2023.

Type II Variations scope of the Variations: Extension of indication

Abecma - idecabtagene vicleucel

Bristol-Myers Squibb Pharma EEIG,

“Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 antibody and have demonstrated disease progression on the last therapy for Abecma (idecabtagene vicleucel, ide-cel), based on results from study BB2121- MM-003 (MM-003, KarMMa-3). This is a Phase 3, multicentre, randomised, open-label study to compare the efficacy and safety of ide-cel versus standard regimens in subjects with RRMM. As a consequence, sections 2.1, 2.2, 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 6.3, 6.4 and 6.6 of the SmPC are updated. The Package Leaflet and Labelling are updated in accordance. EMA/CHMP/148206/2023  Version 3.0 of the RMP has also been submitted. Furthermore, the PI is brought in line with the Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.” Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC) 726/2004)