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RSS FeedPosted by Michael Wonder on 30 Aug 2022
Novartis Scemblix, with novel mechanism of action, approved by the European Commission for adult patients with chronic myeloid leukaemia
29 August 2022 - Approval based on results from pivotal Phase 3 ASCEMBL trial, in which Scemblix (asciminib) nearly doubled the ...
Posted by Michael Wonder on 25 Aug 2022
Janssen marks first approval worldwide for Tecvayli (teclistamab) with EC authorisation of first in class bispecific antibody for the treatment of patients with multiple myeloma
24 August 2022 - Teclistamab, an off the shelf subcutaneously administered therapy, induced deep and rapid responses in triple class ...
Posted by Michael Wonder on 23 Aug 2022
European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...
Posted by Michael Wonder on 23 Aug 2022
Quizartinib marketing authorisation application validated by EMA for treatment of adult patients with newly diagnosed FLT3- ITD positive acute myeloid leukaemia
23 August 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
Posted by Michael Wonder on 23 Aug 2022
Menarini Group’s elacestrant marketing authorisation application accepted for review by the EMA for the treatment of ER+/HER2- advanced or metastatic breast cancer
19 August 2022 - Elacestrant, if approved, would be the first oral selective oestrogen receptor degrader to be available for patients ...
Posted by Michael Wonder on 19 Aug 2022
European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma
18 August 2022 - Oncopeptides today announces that the European Commission has granted Pepaxti (melphalan flufenamide) marketing authorisation in combination ...
Posted by Michael Wonder on 11 Aug 2022
European Commission approves Imbruvica (ibrutinib) fixed duration combination for adult patients with previously untreated chronic lymphocytic leukaemia
9 August 2022 - It is the first all oral, fixed duration, once daily treatment based on a Bruton's tyrosine kinase ...
Posted by Michael Wonder on 04 Aug 2022
Lynparza approved in the EU as adjuvant treatment for patients with germline BRCA mutated HER2 negative high-risk early breast cancer
4 August 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer ...
Posted by Michael Wonder on 23 Jul 2022
Kite’s CAR T-cell therapy Tecartus receives positive CHMP opinion in relapsed or refractory acute lymphoblastic leukaemia
22 July 2022 - Tecartus (brexucabtagene autoleucel) first and only CAR T in Europe to receive positive CHMP opinion to ...
Posted by Michael Wonder on 23 Jul 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for LAG-3-blocking antibody combination Opdualag (nivolumab and relatlimab) for treatment of patients with unresectable or metastatic melanoma
22 July 2022 - Recommendation based on results from the Phase 2/3 RELATIVITY-047 trial, in which the fixed-dose combination of the ...
Posted by Michael Wonder on 23 Jul 2022
New medicine for multiple myeloma patients with limited treatment options
22 July 2022 - The EMA has recommended a conditional marketing authorisation in the European Union for Tecvayli (teclistamab) for ...
Posted by Michael Wonder on 22 Jul 2022
EMA recommends restricting use of cancer medicine Rubraca
22 July 2022 - EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used ...
Posted by Michael Wonder on 21 Jul 2022
Karyopharm and Menarini receive full marketing authorisation from the European Commission for Nexpovio (selinexor) for the treatment of patients with multiple myeloma after at least one prior therapy
21 July 2022 - Based on Results from Phase 3 BOSTON Study, Marketing Authorisation Expands Multiple Myeloma Indication. ...
Posted by Michael Wonder on 19 Jul 2022
Genmab announces that AbbVie will submit marketing authorisation application to EMA for epcoritamab for the treatment of relapsed/refractory diffuse large B-cell lymphoma
18 July 2022 - Genmab today announced that AbbVie will submit a conditional marketing authorisation application with the EMA for ...
Posted by Michael Wonder on 19 Jul 2022
Enhertu approved in the EU for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2 based regimens
19 July 2022 - Based on groundbreaking DESTINY-Breast03 results in which Enhertu demonstrated a 72% reduction in the risk of ...