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RSS FeedPosted by Michael Wonder on 06 Jun 2025
Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting
6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...
Posted by Michael Wonder on 03 Jun 2025
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with newly diagnosed stage IIb/III/IV Hodgkin lymphoma in combination with ECADD
3 June 2025 - Approval based on positive results from the Phase 3 HD21 trial for stage IIb with risk factors/III/IV ...
Posted by Michael Wonder on 27 May 2025
Imfinzi recommended for approval in the EU by CHMP as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
27 May 2025 - Recommendation based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 25 May 2025
CHMP recommends EU approval of Roche’s Itovebi for PIK3CA mutated, ER positive, HER2 negative, advanced breast cancer
23 May 2025 - Positive recommendation based on Phase 3 INAVO120 data showing Itovebi (inavolisib) in combination with palbociclib and fulvestrant ...
Posted by Michael Wonder on 22 May 2025
PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumab in first-line maintenance therapy for extensive-stage small cell lung cancer
21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...
Posted by Michael Wonder on 16 May 2025
BMS receives European Commission approval for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by adjuvant Opdivo for resectable, high risk non-small cell lung cancer with PD-L1 expression ≥1%
16 May 2025 - Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared ...
Posted by Michael Wonder on 06 May 2025
Calquence plus chemoimmunotherapy approved in the EU as first and only BTK inhibitor for first-line mantle cell lymphoma
6 May 2025 - Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 29 Apr 2025
Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for first-line chronic lymphocytic leukaemia
29 April 2025 - Recommendation based on AMPLIFY Phase III trial which showed Calquence combinations demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 14 Apr 2025
European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy
14 April 2025 - Approval based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction ...
Posted by Michael Wonder on 08 Apr 2025
Datroway approved in the EU for patients with previously treated metastatic HR positive, HER2 negative breast cancer
8 April 2025 - Second DXd antibody drug conjugate approved in EU based on Daiichi Sankyo’s DXd technology ...
Posted by Michael Wonder on 04 Apr 2025
Imfinzi-based peri-operative regimen approved in the EU for resectable non-small cell lung cancer
4 April 2025 - Approval based on AEGEAN Phase 3 trial results which showed a 32% reduction in the risk ...
Posted by Michael Wonder on 04 Apr 2025
Enhertu approved in the EU as first HER2 directed therapy for patients with HR positive, HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
4 April 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 04 Apr 2025
Bristol Myers Squibb receives positive CHMP opinion for the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumour indications
28 March 2025 - A decision on the EU Opdivo extension of marketing authorisation is expected by 2 June 2025 ...
Posted by Michael Wonder on 01 Apr 2025
Tivdak (tisotumab vedotin) approved by European Commission for previously treated recurrent or metastatic cervical cancer
31 March 2025 - In the global Phase 3 innovaTV 301 clinical trial Tivdak demonstrated superior overall survival compared to chemotherapy. ...
Posted by Michael Wonder on 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for first-line mantle cell lymphoma
31 March 2025 - Recommendation based on ECHO Phase 3 trial results which demonstrated over 16 months of progression-free survival ...