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RSS FeedPosted by Michael Wonder on 21 Feb 2024
FDA and EMA accept vorasidenib regulatory submissions for the treatment of IDH mutant diffuse glioma
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
Posted by Michael Wonder on 10 Feb 2024
Janssen submits type II extension of indication application to the EMA seeking approval of Rybrevant (amivantamab), in combination with lazertinib, for first-line treatment of patients with EGFR mutated non-small-cell lung cancer
8 February 2024 - The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically ...
Posted by Michael Wonder on 02 Feb 2024
Linvoseltamab receives EMA filing acceptance for treatment of relapsed/refractory multiple myeloma
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...
Posted by Michael Wonder on 26 Jan 2024
Bristol Myers Squibb receives positive CHMP opinion for CAR T-cell therapy Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple class exposed relapsed and refractory multiple myeloma
26 January 2024 - Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, ...
Posted by Michael Wonder on 26 Jan 2024
European Medicines Agency validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival. ...
Posted by Michael Wonder on 17 Jan 2024
European Commission approves Roche’s Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
16 January 2024 - Roche is working closely with national health systems in Europe to ensure patients can access Tecentriq ...
Posted by Michael Wonder on 12 Jan 2024
European Commission approves Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small-cell lung cancer with a KRAS G12C mutation
10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
Posted by Michael Wonder on 10 Jan 2024
European Commission approves Pfizer’s Talzenna in combination with Xtandi for adult patients with metastatic castration resistant prostate cancer
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...
Posted by Michael Wonder on 02 Jan 2024
European Medicines Agency validates Bristol Myers Squibb’s application for repotrectinib for the treatment of locally advanced or metastatic ROS1 positive non-small cell lung cancer and NTRK positive solid tumours
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
Posted by Michael Wonder on 21 Dec 2023
Janssen submits marketing authorisation application to the EMA seeking approval of lazertinib, in combination with Rybrevant (amivantamab), for the first-line treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
Posted by Michael Wonder on 20 Dec 2023
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy for new first-line indications in advanced HER2 negative gastric or GEJ adenocarcinoma in tumours expressing PD-L1 (CPS ≥1) and advanced biliary tract cancer
18 December 2023 - Keytruda now approved for 26 indications in the EU, including seven in gastro-intestinal cancers. ...
Posted by Michael Wonder on 11 Dec 2023
GSK’s Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer
11 December 2023 - European Commission also converts previous conditional approval for Jemperli to full approval as a monotherapy for ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 25 Nov 2023
Janssen submits application to the EMA for 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
23 November 2023 - The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking ...
Posted by Michael Wonder on 22 Nov 2023
EC approves pharmaand’s Rubraca as advanced ovarian cancer maintenance treatment
21 November 2023 - The European Commission has approved pharmaand’s Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer ...