Blog
RSS FeedPosted by Michael Wonder on 23 Sep 2024
Henlius and Intas receive positive CHMP opinion for Hetronifly in European markets as first-line treatment for adult patients with extensive-stage small cell lung cancer
21 September 2024 - Hetronifly (serplulimab) is expected to become the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment ...
Posted by Michael Wonder on 21 Sep 2024
Astellas receives approval from the European Commission for Vyloy (zolbetuximab) in combination with chemotherapy for advanced gastric and gastro-oesophageal junction cancer
20 September 2024 - Treatment with the claudin 18.2 targeted monoclonal antibody shown to significantly extend both progression-free survival and ...
Posted by Michael Wonder on 20 Sep 2024
AbbVie receives positive CHMP opinion for mirvetuximab soravtansine (Elahere) for the treatment of certain adult ovarian cancer
20 September 2024 - AbbVie today announced that the EMA's CHMP has adopted a positive opinion recommending the marketing authorisation of ...
Posted by Michael Wonder on 11 Sep 2024
Pierre Fabre Laboratories receives European Commission approval for Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation
30 August 2024 - European approval is based on results from the Phase 2 PHAROS trial, which showed a meaningful ...
Posted by Michael Wonder on 29 Aug 2024
European Commission approves Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer after failure of prior therapy
27 August 2024 - Amivantamab in combination with chemotherapy is the first treatment regimen to show significant improvement in progression-free survival ...
Posted by Michael Wonder on 28 Aug 2024
European Commission approves Astellas' Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced urothelial cancer
28 August 2024 - European marketing authorisation based on positive overall survival and progression-free survival results from the global Phase ...
Posted by Michael Wonder on 26 Aug 2024
Ordspono (odronextamab) approved in the European Union for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
26 August 2024 - Approval of Ordspono is based on data demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma ...
Posted by Michael Wonder on 26 Aug 2024
European Commission approves Balversa (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma
23 August 2024 - Approval based on THOR results, showing 36 percent reduction in risk of death with erdafitinib versus ...
Posted by Michael Wonder on 20 Aug 2024
European Commission grants second indication approval for Tepkinly (epcoritamab) for the treatment of adults with relapsed/refractory follicular lymphoma
20 August 2024 - AbbVie today announced that the European Commission has granted conditional marketing authorisation for Tepkinly (epcoritamab) as a ...
Posted by Michael Wonder on 19 Aug 2024
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
19 August 2024 - Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu type II variation application validated by EMA for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
19 August 2024 - Submission based on DESTINY-Breast06 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated ...
Posted by Michael Wonder on 14 Aug 2024
Lynparza and Imfinzi combination approved in the EU for patients with mismatch repair proficient advanced or recurrent endometrial cancer
14 August 2024 - First immunotherapy and PARP inhibitor combination approved in endometrial cancer. ...
Posted by Michael Wonder on 01 Aug 2024
CHMP recommends Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR mutated non-small cell lung cancer after failure of prior therapy
31 July 2024 - CHMP recommends Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced ...
Posted by Michael Wonder on 29 Jul 2024
CStone announces European Commission approval of Sugemalimab (Cejemly) as first-line treatment for non-small cell lung cancer
26 July 2024 - The European Commission approval is based on the results of GEMSTONE-302 Phase 3 trial, which demonstrated that ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for zolbetuximab in combination with chemotherapy for treatment of advanced gastric and gastro-oesophageal junction cancer
26 July 2024 - If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2 targeted therapy approved ...