What's new

Extension of indication to include KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resactable muscle invasive bladder cancer (MIBC) who are eligible for cisplatin containing chemotherapy, based on the results from Interim Analysis 1 of the pivotal Study KN-B15 (EV-304); this is a phase 3, randomized, open-label study to evaluate perioperative enfortumab vedotin plus pembrolizumab (MK-3475) versus neoadjuvant gemcitabine and cisplatin in cisplatin-eligible participants with Muscle-Invasive Bladder Cancer.

SmPC 4.1, 4.2, 4.8 and 5.1; package leaflet. Type II variation EMA/VR/0000336194

Extension of indication to include Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are eligible for cisplatin-containing chemotherapy, based on the results from Interim Analysis 1 of the pivotal Study KN-B15 (EV-304); this is a phase 3, randomized, open-label study to evaluate perioperative enfortumab vedotin plus pembrolizumab (MK-3475) versus neoadjuvant gemcitabine and cisplatin in cisplatin-eligible participants with Muscle-Invasive Bladder Cancer.

SmPC 4.1, 4.2, 4.8 and 5.1; package leaflet. Type II variation EMA/VR/0000336191

Extension of indication for PIQRAY in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen; based on the primary analysis (DCO 15-Oct-2024) from the Phase III Study CBYL719C2303 (C2303, EPIK-B5).

SmPC 4.2, 4.4, 4.8, 5.1 and 5.2; package leaflet. Type II variation EMA/VR/0000317159

Extension of indication for Trodelvy in combination with pembrolizumab for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10, based on the results from study GS-US-592-6173 (ASCENT-04), which is a phase 3 study of sacituzumab govitecan (IMMU-132) and pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab in patients with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumours express PD-L1.

SmPC 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2; package leaflet. Type II variation EMA/VR/0000320818

Extension of indication to include in combination with daratumumab treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy for TECVAYLI, based on interim analysis data from the pivotal study MajesTEC-3 (64007957MMY3001). This is an on-going multicentre, randomised, open-label, Phase 3 study to determine whether adding teclistamab to daratumumab (Tec-Dara) is more efficacious than adding pomalidomide/dexamethasone (DPd) or bortezomib/dexamethasone (DVd) to daratumumab in participants with multiple myeloma who previously received 1 to 3 prior line(s) of therapy.

SmPC 4.1, 4.2, 4.4, 4.7, 4.8, 5.1, 5.2 and 6.6; Annex II; package leaflet. Type II variation EMA/VR/0000322279

A grouped application, comprised of the following variations: Update of sections 4.8, 5.1 and 5.2 of the SmPC to introduce changes based on the final results from study APN311-304; this is a Phase II, interventional, single-arm, open-label study evaluating the anti-tumor activity and safety of dinutuximab beta (ch14.18/CHO) continuous infusion in pediatric patients with primary refractory or relapsed neuroblastoma. The Package Leaflet has been updated accordingly.

SmPC 4.8, 5.1 and 5.2; Annex II; package leaflet. Type II variation EMA/VR/0000316241

Update of section 4.4 of the SmPC in order to provide the treating physician the option to determine the setting of the post-infusion monitoring, while maintaining the requirement for monitoring during the period and the proximity to a qualified centre following infusion; the Package Leaflet is updated accordingly. The RMP version 8.3 has also been submitted. In addition, the MAH took the opportunity to introduce minor editorial and formatting changes to the PI.

SmPC 4.4; package leaflet. Type II variation EMA/VR/0000365288

Update of section 5.3 of the SmPC in order to update preclinical safety information based on final results from rat carcinogenicity study MK-6482. In addition, the MAH took the opportunity to implement editorial changes to the PI.

SmPC 5.3. Type II variation EMA/VR/0000347680

Periodic Safety Update EU Single assessment - enfortumab vedotin

SmPC; package leaflet. Periodic safety update assessment PSUSA/00010989/202512

Periodic Safety Update EU Single assessment - tabelecleucel

SmPC; package leaflet. Periodic safety update assessment PSUSA/00011028/202512

Post-Authorisation Safety Study

SmPC; Annex II. Post-authorisation safety study EMA/PASS/0000262863

Periodic Safety Update EU Single assessment - mosunetuzumab

SmPC; package leaflet. Periodic safety update assessment PSUSA/00010999/202512

EURD: PSUSA/00000136/202512 Active

SmPC; package leaflet. Periodic safety update assessment PSUSA/00000136/202512