Oncology Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) meeting on 24-26 April 2023 released on the 06th of July 2023.

Minutes from the EMA’s Committee for Medicinal Products for Human Use (CHMP) meeting on 24-26 April 2023 released on the 06^th of July 2023. Items of interest listed below:

Post-authorisation procedure oral explanations

Opdivo - nivolumab - Bristol-Myers Squibb Pharma EEIG

• “Extension of indication to include Opdivo in combination with platinum-based chemotherapy for neoadjuvant treatment of adult patients with resectable stage IB-IIIA non-small cell lung cancer (NSCLC), based on results from study CA209816; a randomised, open-label, phase 3 trial of nivolumab plus ipilimumab or nivolumab plus platinum-doublet chemotherapy versus platinum-doublet chemotherapy in early-stage NSCLC. As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated.
• The Package Leaflet is updated in accordance. Version 27.0 of the RMP has also been submitted.”
• An oral explanation was held on 24 April 2023. The presentation by the applicant focused on the clinical data in support of the application.

Initial applications; Opinions

Columvi - glofitamab - Orphan - Roche Registration GmbH; treatment of diffuse large B-cell lymphoma

• The Committee confirmed that all issues previously identified in this application had been addressed.
• The Committee adopted a positive opinion recommending the granting of a conditional marketing authorisation by consensus together with the CHMP assessment report and translation timetable.
• Furthermore, the CHMP considered that glofitamab is a new active substance, as claimed by the applicant. The legal status was agreed as medicinal product subject to restricted medical prescription. The summary of opinion was circulated for information. The CHMP adopted the similarity assessment report.

Jaypirca - pirtobrutinib - Orphan - Eli Lilly Nederland B.V.; treatment of mantle cell lymphoma (MCL)

• The Committee adopted a positive opinion recommending the granting of a conditional marketing authorisation by consensus together with the CHMP assessment report and translation timetable.
• Furthermore, the CHMP considered that pirtobrutinib is a new active substance, as claimed by the applicant. The legal status was agreed as medicinal product subject to restricted medical prescription. The summary of opinion was circulated for information. The CHMP adopted the similarity assessment report.

Lytgobi - futibatinib - Orphan - Taiho Pharma Netherlands B.V.; treatment of cholangiocarcinoma

• The Committee adopted a positive opinion by majority (26 out of 28 votes) recommending the granting of a conditional marketing authorisation together with the CHMP assessment report and translation timetable.
• Furthermore, the CHMP considered that futibatinib is a new active substance, as claimed by the applicant. The legal status was agreed as medicinal product subject to restricted medical prescription. The divergent position (Martina Weise and Armando Genazzani) was appended to the opinion. The CHMP noted the letter of recommendation dated 26 April 2023. The summary of opinion was circulated for information. The CHMP adopted the similarity assessment report.

Initial applications; List of questions (Day 120; Day 90 for procedures with accelerated assessment timetable)

azacitidine -

• The Committee discussed the issues identified in this application.
• The Committee adopted the CHMP recommendation and scientific discussion together withthe list of questions.

talquetamab - Orphan -Janssen-Cilag International N.V.; monotherapy treatment of adult patients with relapsed and refractory multiple myeloma

• Accelerated assessment
• The Committee discussed the issues identified in this application.
• The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions.

Withdrawals of initial marketing authorisation application

Tidhesco - ivosidenib - Orphan - Les Laboratoires Servier; treatment of acute myeloid leukaemia

• The CHMP noted the withdrawal of the marketing authorisation application.

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

Iclusig - ponatinib - Orphan - Incyte Biosciences Distribution B.V.

• “Extension of indication to include treatment of newly diagnosed adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), either with Iclusig (ponatinib) in combination with chemotherapy, or with Iclusig (ponatinib) monotherapy after corticosteroid induction in patients not eligible to receive chemotherapy based regimens, based on final results from studies AP24534-11-001 and INCB 84344-201.
• As a consequence, sections 4.1, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 22 of the RMP has also been submitted.”
• The Committee adopted a 2nd request for supplementary information with a specific timetable.

Opdivo - nivolumab - Bristol-Myers Squibb Pharma EEIG

• Extension of indication to include Opdivo in combination with platinum-based chemotherapy for neoadjuvant treatment of adult patients with resectable stage IB-IIIA non-small cell lung cancer (NSCLC), based on results from study CA209816; a randomised, open-label, phase 3 trial of nivolumab plus ipilimumab or nivolumab plus platinum-doublet chemotherapy versus platinum-doublet chemotherapy in early-stage NSCLC. As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 27.0 of the RMP has also been submitted.
• The Committee discussed the issues identified in this application. An oral explanation was held on 24 April 2023. The presentation by the applicant focused on the clinical data in support of the application. The Committee adopted a 4th request for supplementary information with a specific timetable.

B.2.2. Renewals of Marketing Authorisations for unlimited validity

Venclyxto - venetoclax - AbbVie Deutschland GmbH & Co. KG,

• Request for supplementary information adopted with a specific timetable.

Verzenios - abemaciclib - Eli Lilly Nederland B.V.,

• Positive Opinion adopted by consensus together with the CHMP assessment report and translation timetable.
• Based on the review of the available information, the CHMP was of the opinion that the renewal of the marketing authorisation can be granted with unlimited validity.

B.2.3. Renewals of Conditional Marketing Authorisations

Abecma - idecabtagene vicleucel - Bristol-Myers Squibb Pharma EEIG

• Positive Opinion adopted by consensus together with the CHMP assessment report.
• The CHMP was of the opinion that the renewal for this conditional Marketing Authorisation can be granted. The Marketing Authorisation remains conditional.

Blenrep - belantamab mafodotin - GlaxoSmithKline (Ireland) Limited,

• Request for supplementary information adopted with a specific timetable.

Rozlytrek - entrectinib - Roche Registration GmbH,

• Positive Opinion adopted by consensus together with the CHMP assessment report.
• The CHMP was of the opinion that the renewal for this conditional Marketing Authorisation can be granted. The Marketing Authorisation remains

B.3. POST-AUTHORISATION PHARMACOVIGILANCE OUTCOMES

Abecma (idecabtagene vicleucel), Bristol-Myers Squibb Pharma EEIG,

• The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the above mentioned medicinal product(s), concerning the following change(s): Update of section 4.4 of the SmPC to add warning information on Parkinsonism and to mention it in the footnotes of the table in section 4.8 of the SmPC for the SOC “Nervous system disorders”.

Gavreto (pralsetinib) - Roche Registration GmbH

• The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the above mentioned medicinal product(s), concerning the following change(s): Update of sections 4.4 and 4.8 of the SmPC to add the adverse reaction ‘tuberculosis’ with a frequency uncommon and a warning/precaution regarding tuberculosis. The package leaflet is updated accordingly.

B.6.10.  CHMP-PRAC assessed procedures

Enhertu - trastuzumab deruxtecan - Daiichi Sankyo Europe GmbH

• Update of sections 4.8, 5.1 and 5.2 of the SmPC in order to update safety, efficacy and pharmacokinetic information based on data from study DS8201-A-U301 and study DS8201-A-U302. Study U301 was a Phase 3, randomized, 2-arm, open-label, multicenter study designed to compare the safety and efficacy of T-DXd vs TPC in HER2-positive, unresectable and/or metastatic BC subjects who were resistant or refractory to T-DM1. Study U302 was a Phase 3, multicenter, randomized, open-label, 2-arm, active-controlled study in subjects with unresectable and/or metastatic HER2-positive (IHC 3+ or ISH-positive) BC previously treated with trastuzumab plus taxane in the advanced/metastatic setting or who had progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab plus taxane. The Package Leaflet and Annex II are updated accordingly. The updated RMP version 4.1 has also been submitted.

Document link: CHMP Minutes for the meeting on 24-26 April 2023