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RSS FeedPosted by Michael Wonder on 01 Feb 2021
Merck receives positive EU CHMP opinion for expanded approval of Keytruda (pembrolizumab) in certain patients with relapsed or refractory classical Hodgkin lymphoma
1 February 2021 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to brentuximab vedotin in ...
Posted by Michael Wonder on 01 Feb 2021
Incyte announces positive CHMP opinion for pemigatinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement
29 January 2021 - If approved, pemigatinib will be the first targeted therapy indicated in the EU for this indication. ...
Posted by Michael Wonder on 27 Jan 2021
European Commission approves Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
26 January 2021 - Keytruda is first checkpoint inhibitor approved in Europe to treat MSI-H or dMMR colorectal cancer. ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
25 January 2021 - BAVENCIO maintenance treatment significantly extended median overall survival versus standard of care in the Phase 3 JAVELIN ...
Posted by Michael Wonder on 22 Jan 2021
Menarini receives European Commission approval of Elzonris (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm
21 January 2021 - Elzonris is the first approved treatment for patients with blastic plasmacytoid dendritic cell neoplasm, and the ...
Posted by Michael Wonder on 20 Jan 2021
Enhertu approved in the EU for the treatment of HER2 positive metastatic breast cancer
20 January 2021 - Approval based on the DESTINY-Breast01 Phase 2 trial which showed clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 19 Jan 2021
Tessa Therapeutics receives PRIME designation from European Medicines Agency for CD30 CAR-T therapy
18 January 2021 - Tessa Therapeutics today announced that the EMA has granted PRiority MEdicines (PRIME) designation to the company's lead ...
Posted by Michael Wonder on 15 Jan 2021
Imfinzi approved in the EU for less frequent, fixed dose use in unresectable non-small cell lung cancer
15 January 2021 - New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its Type II Variation marketing authorisation application ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for resected oesophageal or gastro-oesophageal junction cancer following chemoradiotherapy
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its marketing authorisation application for Opdivo (nivolumab) ...
Posted by Michael Wonder on 29 Dec 2020
Janssen submits European marketing authorisation application for amivantamab for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
28 December 2020 - If approved, amivantamab will be the first-ever treatment specifically targeting EGFR exon 20 insertion mutations in the ...
Posted by Michael Wonder on 22 Dec 2020
Amgen submits sotorasib marketing authorisation application to the European Medicines Agency
22 December 2020 - Application is for patients with previously treated non-small cell lung cancer with the KRAS G12C mutation. ...
Posted by Michael Wonder on 17 Dec 2020
Kite’s Tecartus (KTE-X19) granted conditional marketing authorisation for the treatment of relapsed or refractory mantle cell lymphoma in Europe
16 December 2020 - 93% of patients in ZUMA-2 pivotal trial responded to single infusion of Tecartus. ...
Posted by Michael Wonder on 15 Dec 2020
Roche launches cobas PIK3CA mutation test for patients with advanced or metastatic breast cancer in countries accepting the CE mark
15 December 2020 - This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which ...
Posted by Michael Wonder on 15 Dec 2020
Imfinzi recommended for approval in the EU by CHMP for less-frequent, fixed-dose use in unresectable non-small cell lung cancer
15 December 2020 - Option would extend dosing from two to four weeks, reducing medical visits and improving patient convenience ...