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RSS FeedPosted by Michael Wonder on 13 Sep 2023
European Medicines Agency validates type II variation for Astellas' Xtandi (enzalutamide) for treatment of non-metastatic hormone sensitive prostate cancer with high risk biochemical recurrence
13 September 2023 - Application based on results from Phase 3 EMBARK trial, which showed Xtandi plus leuprolide reduced risk ...
Posted by Michael Wonder on 09 Sep 2023
Janssen submits marketing authorisation application to the EMA seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer with susceptible FGFR alterations
8 September 2023 - The submission is based on results from the Phase 3 THOR study, which were featured in ...
Posted by Michael Wonder on 30 Aug 2023
Withdrawn accelerated approvals for cancer indications in the US: what is the marketing authorisation status in the EU?
30 August 2023 - As of April, 2023, 23 accelerated approvals for cancer indications granted by the US FDA since 1992 ...
Posted by Michael Wonder on 30 Aug 2023
European Commission approves Keytruda (pembrolizumab) plus trastuzumab and chemotherapy as first-line treatment for HER2 positive advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
29 August 2023 - Approval based on progression-free survival benefit demonstrated in Phase 3 KEYNOTE-811 trial. ...
Posted by Michael Wonder on 24 Aug 2023
Cancer treatment uncertainty: European nations struggle with drug shortages
21 August 2023 - Experts in Europe detail the challenge with current cancer drug shortages and how regulators are trying ...
Posted by Michael Wonder on 23 Aug 2023
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
22 August 2023 - Approval based on results from the Phase 3 CheckMate-76K trial in patients with stage IIB or ...
Posted by Michael Wonder on 21 Aug 2023
European Commission approves reduced dosing frequency for Janssen’s bispecific antibody Tecvayli (teclistamab)
18 August 2023 - Teclistamab, the first BCMA-targeting bispecific antibody to receive approval in Europe, maintained deep and durable responses, with ...
Posted by Michael Wonder on 17 Aug 2023
Odronextamab receives EMA filing acceptance for treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
17 August 2023 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for odronextamab ...
Posted by Michael Wonder on 29 Jul 2023
European Commission approves Gilead’s Trodelvy for pre-treated HR positive, HER2 negative metastatic breast cancer
27 July 2023 - Approval based on clinically meaningful overall survival benefit demonstrated in the TROPiCS-02 study in pre-treated HR+/HER2- (IHC ...
Posted by Michael Wonder on 24 Jul 2023
Jazz Pharmaceuticals receives CHMP positive opinion for JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma
21 July 2023 - Jazz Pharmaceuticals today announced that the EMA's CHMP adopted a positive opinion recommending the marketing authorisation of ...
Posted by Michael Wonder on 22 Jul 2023
Janssen receives positive CHMP opinions for novel bispecific antibodies Talvey (talquetamab) and Tecvayli (teclistamab) for the treatment of patients with relapsed and refractory multiple myeloma
21 July 2023 - Talquetamab is the first therapy targeting GPRC5D to receive a positive CHMP opinion. ...
Posted by Michael Wonder on 22 Jul 2023
BeiGene announces positive CHMP opinion for tislelizumab as a treatment for advanced or metastatic oesophageal squamous cell carcinoma
21 July 2023 - BeiGene today announced that the CHMP of the EMA has issued a positive opinion recommending approval ...
Posted by Michael Wonder on 22 Jul 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus trastuzumab and chemotherapy as first-line treatment for HER2 positive advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
21 July 2023 - Opinion granted based on positive progression-free survival results from the Phase 3 KEYNOTE-811 trial. ...
Posted by Michael Wonder on 22 Jul 2023
Menarini Group receives positive CHMP opinion recommending EC approval of Orserdu (elacestrant) for the treatment of patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation
21 July 2023 - If approved by the European Commission, Orserdu would be the first and only treatment specifically indicated for ...
Posted by Michael Wonder on 21 Jul 2023
AbbVie receives positive CHMP opinion for epcoritamab (Tepkinly) for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma
21 July 2023 - The positive CHMP opinion is supported by results from the EPCORE NHL-1 Phase 1/2 trial evaluating the ...