EMA: minute del CHMP Marzo 2022 (tumori solidi)

Sono state rese disponibili le minute del CHMP di Marzo 2022 (documento integrale disponibile qui CHMP Meeting Minutes March 2022).

Pre-authorisation procedure oral explanations

• Capmatinib
  • Indication: treatment of non-small cell lung cancer (NSCLC)
  • The CHMP agreed that an oral explanation was not needed at this time.

Post-authorisation procedure oral explanations

• Keytruda (pembrolizumab) – Merck
  • Extension of indication for Keytruda as monotherapy for the treatment of the following microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumours in adults with: -unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy; -advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation; -unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. The proposed indication is based on the results from the KEYNOTE-164 (KN164) and KEYNOTE-158 (KN158) trials. As a consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. An updated version of the RMP (version 35) has been submitted.
  • The CHMP agreed that an oral explanation was not needed at this time.

Initial applications; Opinions

• Zolsketil pegylated liposomal (doxorubicin)(Hybrid) – Accord
  • Indication: treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma
  • The Committee adopted a positive opinion recommending the granting of a marketing authorisation

Initial applications; List of outstanding issues

• doxorubicin hydrochloride
  • Indication: treatment of breast cancer, treatment of ovarian cancer, treatment of multiple myeloma, treatment of AIDS related Kaposi's sarcoma
  • The Committee adopted a list of outstanding issues with a specific timetable.

Type II variations

• Enhertu (trastuzumab deruxtecan) - Daiichi Sankyo Europe
  • Extension of indication for Enhertu to include treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens; as a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 1.2 of the RMP has also been submitted.
  • The Committee adopted a request for supplementary information with a specific timetable.
• Keytruda (pembrolizumab) – Merck
  • Extension of indication for Keytruda as monotherapy for the treatment of the following microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumours in adults with: -unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy; -advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation; -unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. The proposed indication is based on the results from the KEYNOTE-164 (KN164) and KEYNOTE-158 (KN158) trials. As a consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. An updated version of the RMP (Version 35) has been submitted.
  • The Committee adopted a positive opinion by majority (29 positive out of 31 votes) together with the CHMP Assessment Report and translation timetable.
  • The divergent position (Johann Lodewijk Hillege, Outi Maki-Ikola) was appended to the opinion.
  • Extension of indication to include a new indication for Keytruda, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults; as a consequence, sections 4.1 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 38.1 of the RMP has also been submitted.
  • The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
• Tecentriq (atezolizumab) – Roche
  • C.I.6 (Extension of indication) Extension of indication to include adjuvant treatment of non-small cell lung cancer (NSCLC) following resection and platinum-based chemotherapy for adult patients whose tumours have PD-L1 expression on ≥ 1% of tumour cells (TC) for Tecentriq as monotherapy based on the results from the pivotal phase III study GO29527 (IMpower010); as a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of both the Tecentriq 840 mg concentrate for solution for infusion SmPC and the Tecentriq 1,200 mg concentrate for solution for infusion SmPC are updated. Minor editorial changes have been made throughout the SmPC. The Package Leaflets are updated in accordance. Version 21.0 of the RMP has also been submitted.
  • The Committee discussed the issues identified in this application, concerning clinical aspects.
  • The Committee adopted a 2nd request for supplementary information with a specific timetable.

Update on on-going Type II variations

• Enhertu (trastuzumab deruxtecan) – Daiichi Sankyo Europe
  • Extension of indication to include monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen for Enhertu based on final results from studies DS8201 A J202 (DESTINY Gastric01) and DS8201-A-U205 (DESTINY Gastric02); as a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. In addition, changes regarding the dosing recommendation for corticosteroid treatment and the protection of the infusion bag from light have been introduced. Version 1.1 of the RMP has also been submitted.
  • The CHMP agreed to an extension to the clock stop to respond to the request of supplementary information adopted in January 2022.

Post-authorisation issues

• Piqray (alpelisib) – Novartis
  • Update of section 5.1 of the SmPC based on final results from study CBYL719C2301 (SOLAR-1) listed as a PAES in the Annex II; this is a phase III, randomized, double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment; the Annex II is updated accordingly. In addition, the MAH is updating the ATC code in the SmPC. The RMP version 5.0 has also been submitted.
  • The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
• Keytruda (pembrolizumab) – Merck
  • Update of section 5.1 of the SmPC in order to update efficacy information based on final results from study KEYNOTE-426 listed as imposed PAES in the Annex II; this is a Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC).
  • The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.

Renewals of Conditional Marketing Authorisations

• Rozlytrek (entrectinib) - Roche
  
  • The CHMP believed the renewal for this conditional Marketing Authorisation can be granted.
  • The Marketing Authorisation remains conditional.

EPARs / WPARs

• Padcev (enfortumab vedotin) (NAS) - Astellas
  • • Indication treatment of locally advanced (LA) or metastatic urothelial cancer (mUC)

CHMP assessed procedures scope: Non-Clinical and Clinical aspects

• Keytruda (pembrolizumab) - Merck
  • Update of section 5.1 of the SmPC in order to update efficacy information based on final results from study KEYNOTE-426 listed as imposed PAES in the Annex II; this is a Phase III Randomized, Openlabel Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in combination with Axitinib versus Sunitinib Monotherapy as a Firstline Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC). In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet.
  • Positive Opinion adopted by consensus on 24.03.2022.
• Retsevmo (selpercatinib) - Eli Lilly
  • “Update of sections 4.2 and 5.3 of the SmPC in order to reflect the need to monitor open growth plates in adolescent patients based on the results from a non-clinical juvenile toxicity study LOXO-292-TOX-028. The Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to correct figures in section 5.1 of the SmPC.” Request for Supplementary Information adopted on 24.03.2022, 16.12.2021.

CHMP-PRAC assessed procedures

• Mekinist (trametinib) - Novartis
  • “Update of sections 4.2 and 5.2 of the SmPC in order to change posology recommendations in hepatic impairment and update pharmacokinetic information based on final results from study MEC116354 listed as a category 3 study in the RMP; this is a Phase I Trial of Single Agent Trametinib (GSK1120212) in Advanced Cancer Patients with Hepatic Dysfunction. The RMP version 18 has also been submitted.” Positive opinion adopted on 24.03.2022. Request for Supplementary Information adopted on 16.12.2021.
• Piqray (alpelisib) – Novartis
  • “Update of section 5.1 of the SmPC based on final results from study CBYL719C2301 (SOLAR-1) listed as a PAES in the Annex II; this is a phase III, randomized, double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment; the Annex II is updated accordingly. In addition, the MAH is updating the ATC code in the SmPC. The RMP version 5.0 has also been submitted.”
  • Positive Opinion adopted by consensus on 24.03.2022.

Restart of procedure - responses received to Day 120 List of Questions timetables: for information

• mobocertinib
  • Indication: Treatment of adult patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • List of Questions adopted on 11.11.2021.  
• pemetrexed
  • Indication: treatment of malignant pleural mesothelioma and non-small cell lung cancer List of Questions adopted on 16.12.2021
• bevacizumab
  • Indication: Treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer. First-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer. First-line treatment of patients with advanced and/or metastatic renal cell cancer.
  • List of Questions adopted on 24.02.2022.