Haematological competitors updates from CHMP Meeting Minutes

Initial applications 

• Asciminib (Orphan) - Novartis
  • Indication: treatment of Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP)
  • The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions.

Update on on-going initial applications for Centralised procedure

• Melphalan flufenamide (Orphan) - Oncopeptides AB
  • Indication: treatment of multiple myeloma
  • Letter from the applicant dated 04 November 2021 requesting an extension to the clock stop to respond to the list of questions adopted in September 2021.
  • The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the list of questions adopted in September 2021.

Type II variations 

• Vyxeos liposomal (daunorubicin / cytarabine) (Orphan) - Jazz Pharmaceuticals
  • “Extension of indication to add treatment of relapsed/refractory AML in paediatric patients with subsequent updates to sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC based on the new safety and efficacy data from the paediatric clinical study AAML1421. The Package leaflet is updated accordingly. The RMP version 1.1 has also been submitted. In addition, the PI is updated in line with the latest QRD template 10.2. Submission of the final data from paediatric clinical study CPX-MA-1201 in support of the extension of indication.” Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC) 726/2004)
  • The Committee adopted a 2nd request for supplementary information with a specific timetable.

POST-AUTHORISATION PROCEDURES OUTCOMES

• Atriance (nelarabine) - Novartis
  • Positive Opinion adopted by consensus together with the CHMP assessment report.
  • The Marketing Authorisation remains under exceptional circumstances.

Renewals of Marketing Authorisations for unlimited validity

• Darzalex (daratumumab) (Orphan) - Janssen-Cilag
  • Positive Opinion adopted by consensus together with the CHMP assessment report and translation timetable.
  • The CHMP believed the renewal of the marketing authorisation can be granted with unlimited validity.
• LEDAGA (chlormethine) (Orphan) - Helsinn Birex Pharmaceuticals
  • Request for Supplementary Information adopted on 16.09.2021.
  • Positive Opinion adopted by consensus together with the CHMP assessment report and translation timetable.
  • Based on the review of the available information, the CHMP believed the renewal of the marketing authorisation can be granted with unlimited validity.

CHMP assessed procedures scope: Pharmaceutical aspects

• MabThera (rituximab) - Roche
  • Request for Supplementary Information adopted
  • Positive Opinion adopted by consensus on 28.10.2021.
• Rixathon, Riximyo - Sandoz GmbH
  • Positive Opinion adopted by consensus on 28.10.2021.
• Blitzima, Truxima - Celltrion Healthcare
  • Request for Supplementary Information adopted on 11.11.2021 with a specific timetable.

CHMP assessed procedures scope: Non-Clinical and Clinical aspects

• Calquence (acalabrutinib) - AstraZeneca
  • “Submission of the final report of the nonclinical study 20266648 (5336BV) (Acalabrutinib: Neutral Red Uptake Phototoxicity Assay in BALB/c 3T3 Mouse Fibroblasts), in response to the CHMP recommendation to submit results from a modified 3T3 NRU phototoxicity study with adjusted wavelengths. SmPC sections 4.4 and 5.3 were updated accordingly.”
  • Positive Opinion adopted by consensus on 11.11.2021.
• Copiktra (duvelisib) - Secura Bio Limited
  • “Update of section 5.1 of the SmPC based on the final overall survival results from study IPI-145-07, an interventional Phase 3 study of duvelisib (IPI-145) vs ofatumumab in patients with relapsed or refractory Chronic Lymphocytic leukemia/Small Lymphocytic Lymphoma.”
  • Request for Supplementary Information adopted on 11.11.2021 with a specific timetable.
• Empliciti (elotuzumab) - Bristol-Myers
  • “C.I.4: Update of section 5.1 of the SmPC in order to update efficacy data from the final CSR for study CA204125. This is an open label, randomized phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in RRMM. In addition, the MAH took the opportunity to remove the list of local representatives in the Package Leaflet and update the address of the manufacturer.”
  • Positive Opinion adopted by consensus on 21.10.2021.
• Rydapt (midostaurin) (Orphan) - Novartis
  • “Update of section 5.1 of the SmPC in order to update efficacy information in elderly patients, based on final results from study ADE02T listed as PAES in the Annex II; this is a phase II study to investigate the efficacy of midostaurin in combination with intensive induction, consolidation including allogenic SCT and single agent maintenance in patients aged 18-70 with FLT3 ITD mutated AML .”

CHMP-PRAC assessed procedures

• ADCETRIS (brentuximab vedotin) (Orphan) - Takeda Pharma
  • “Update of sections 4.2, 4.8, 5.1, 5.2 and 6.6 of the SmPC based on the final results from study C25004, an open-label study in order to assess the safety and tolerability, of brentuximab vedotin when combined with multiagent chemotherapy regimen for first-line treatment of advanced-stage Hodgkin lymphoma in paediatric patients, in order to complete the PIP (P/0013/2021) and in order to fulfil Article 46 of Regulation EC No 1901/2006. The RMP version 16 has also been submitted.”
  • Positive Opinion adopted by consensus on 11.11.2021.
• Rydapt (midostaurin) (Orphan) - Novartis
  • 6 - Administrative change - Change in ATC Code/ATC Vet Code C.I.4, Update of the SmPC in section 4.5 to add drug-drug interaction information with P-gp, BCRP, CYP2D6, substrates (digoxin, rosuvastatin, and dextromethorphan), based on final results from study CPKC412A2121, a Phase 1, open-label, drug-drug interaction study, listed as category 3 study in the RMP; section 5.2 of the SmPC and the Package Leaflet is updated accordingly.
  • (MEA 005.3) C.I.4, Update of the SmPC in section 4.5 to add drug-drug interaction information with CYP2B6, CYP2C8, CYP3A4 substrates, based on final results from study CPKC412A2122, a Phase 1, open-label, drug-drug interaction study, listed as category 3 study in the RMP; section 5.2 of the SmPC and the Package Leaflet is updated accordingly.
  • (MEA 007.2) C.I.4 Update of the SmPC in section 4.5 to add drug-drug interaction information with oral contraceptives, and section 4.6 to update information on pregnancy and contraception based on final results from study CPKC412A2123, a Phase 1, open-label, drug-drug interaction study, listed as category 3 study in the RMP; the Package Leaflet is updated accordingly.
  • (MEA 008.2) C.I.4 Update of the SmPC in section 5.2 in order to update pharmacokinetic information on OATP1B1 transporters based on final results from PBPK modelling study DMPK R2000528 listed as category 3 studies in the RMP (MEA 009); C.I.4 Update of the SmPC in section 4.2 in order to amend posology instructions, section 4.4 to amend an existing warning and section 5.2 to update pharmacokinetic information for patients with severe hepatic impairment, based on final results from study CPKC412A2116 listed as category 3 study in the RMP.
  • This is an open label, multiple dose study to evaluate the PK of midostaurin in subjects with mild, moderate and severe hepatic impairment compared to matched healthy subjects; (MEA010) The RMP version 6.0 has also been submitted.
  • In addition, the MAH takes this opportunity to introduce minor changes to edit the wording related to the ethanol excipient in the Package Leaflet, according the Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE-2017-11668), by rounding the volume of alcohol to the next integer number, i.e. from 16.9 to 17 ml.
  • The requested group of variations proposed amendments to the Summary of Product Characteristics and Package Leaflet and to the Risk Management Plan (RMP). Request for Supplementary Information adopted on 11.11.2021, 24.06.2021.

CHMP-CAT assessed procedures

• Abecma (idecabtagene vicleucel) (Orphan)(ATMP) - Celgene
  • Request for Supplementary Information adopted on 05.11.2021.
• Imlygic (talimogene laherparepvec) (ATMP) Amgen
  • Opinion adopted on 11.11.2021, 05.11.2021.

Start of procedure for New Applications: timetables for information

• Plerixafor
  • Indication: treatment of lymphoma and multiple myeloma
• loncastuximab tesirine (Orphan) - FGK Representative Service GmbH
  • Indication: treatment of adult patients with relapsed or refractory large B-cell lymphoma

Souce: minutes-chmp-meeting-8-11-november-2021_en.pdf