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RSS FeedPosted by Michael Wonder on 23 Apr 2024
Astellas' Xtandi (enzalutamide) granted European Commission approval for use in additional recurrent early prostate cancer treatment setting
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone ...
Posted by Michael Wonder on 22 Apr 2024
Carvykti (ciltacabtagene autoleucel) is the first BCMA targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
Posted by Michael Wonder on 03 Apr 2024
Autolus Therapeutics announces acceptance of marketing authorisation application by the EMA for obecabtagene autoleucel for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
Posted by Michael Wonder on 28 Mar 2024
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults
28 March 2024 - Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable non-small cell lung ...
Posted by Michael Wonder on 22 Mar 2024
Astellas receives positive CHMP opinion for Xtandi in additional recurrent early prostate cancer treatment setting
22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk ...
Posted by Michael Wonder on 20 Mar 2024
Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) becomes first CAR T cell therapy approved in the European Union in earlier lines for triple-class exposed relapsed and refractory multiple myeloma
20 March 2024 - Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in ...
Posted by Michael Wonder on 07 Mar 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma
6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...
Posted by Michael Wonder on 04 Mar 2024
Two datopotamab deruxtecan applications validated in the EU for patients with advanced non-squamous non-small cell lung cancer or HR positive, HER2 negative breast cancer
4 March 2024 - Parallel applications based on TROPION-Lung01 and TROPION-Breast01 Phase 3 trial results demonstrating Daiichi Sankyo and AstraZeneca’s ...
Posted by Michael Wonder on 01 Mar 2024
SpringWorks Therapeutics announces EMA validation for marketing authorisation application of nirogacestat for the treatment of adults with desmoid tumours
29 February 2024 - Application based on Phase 3 DeFi trial in which nirogacestat significantly improved progression-free survival and objective response ...
Posted by Michael Wonder on 29 Feb 2024
Added benefit and revenues of oncology drugs approved by the EMA between 1995 and 2020: retrospective cohort study
28 February 2024 - Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the US, ...
Posted by Michael Wonder on 26 Feb 2024
BeiGene receives positive CHMP opinion for tislelizumab as treatment for non-small-cell lung cancer
26 February 2024 - Recommendation based on results of three Phase 3 clinical trials demonstrating benefit of tislelizumab as a first- ...
Posted by Michael Wonder on 24 Feb 2024
Janssen receives positive CHMP opinion for Carvykti (ciltacabtagene autoleucel) for treatment in earlier lines of relapsed and refractory multiple myeloma
23 February 2024 - Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the ...
Posted by Michael Wonder on 24 Feb 2024
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for the treatment of resectable NSCLC at high risk of recurrence
23 February 2024 - Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. ...
Posted 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 ...