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RSS FeedPosted 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 ...
Posted by Michael Wonder on 18 Nov 2023
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma
17 November 2023 - Approval was based on results from the ROSEWOOD trial in which Brukinsa plus the anti-CD20 monoclonal ...
Posted by Michael Wonder on 10 Nov 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus gemcitabine and cisplatin as first-line treatment for locally advanced unresectable or metastatic biliary tract cancer
10 November 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE‑966 trial. ...
Posted by Michael Wonder on 10 Nov 2023
Mirati Therapeutics receives positive opinion from CHMP for Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small cell lung cancer with a KRAS G12C mutation following a re-examination procedure
10 November 2023 - Mirati Therapeutics today announced that following a re-examination procedure, the Company has received a positive opinion ...
Posted by Michael Wonder on 09 Nov 2023
Vanflyta approved in the EU as the first FLT3 inhibitor specifically for patients with newly diagnosed FLT3-ITD positive AML
9 November 2023 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival. ...
Posted by Michael Wonder on 03 Nov 2023
European Medicines Agency validates Pierre Fabre Laboratories' marketing authorisation application for combination Braftovi (encorafenib) and Mektovi (binimetinib) for patients with BRAF V600 mutant advanced non-small cell lung cancer
2 November 2023 - The application is based on results from the PHAROS study, which showed an objective response rate of ...
Posted by Michael Wonder on 30 Oct 2023
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
30 October 2023 - If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for the first-line treatment ...
Posted by Michael Wonder on 28 Oct 2023
ImmunoGen announces European Medicines Agency acceptance of marketing authorisation application for mirvetuximab soravtansine in platinum-resistant ovarian cancer
27 October 2023 - ImmunoGen today announced that the EMA has accepted the marketing authorisation application for mirvetuximab soravtansine (Elahere) ...
Posted by Michael Wonder on 25 Oct 2023
Orphelia Pharma files EU marketing authorisation application for Kizfizo
24 October 2023 - Orphelia Pharma today announces the filing of a centralised marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 23 Oct 2023
Enhertu approved in the EU as the first HER2 directed therapy for patients with HER2 mutant advanced non-small cell lung cancer
23 October 2023 - Approval based on DESTINY-Lung02 trial results where Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a confirmed objective ...
Posted by Michael Wonder on 19 Oct 2023
European Commission approves Keytruda (pembrolizumab) as adjuvant treatment for adults with non-small cell lung cancer at high risk of recurrence following complete resection and platinum-based chemotherapy
16 October 2023 - Decision marks fifth approval for Keytruda in lung cancer in the EU. ...
Posted by Michael Wonder on 19 Oct 2023
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30 positive stage III Hodgkin lymphoma in combination with AVD
18 October 2023 - Approval based on updated positive overall survival results from the Phase 3 ECHELON-1 study for stage III ...
Posted by Michael Wonder on 17 Oct 2023
GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
16 October 2023 - If approved, dostarlimab would become the first new frontline treatment option in the European Union in ...
Posted by Michael Wonder on 13 Oct 2023
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) in relapsed or refractory follicular lymphoma
13 October 2023 - If approved, Brukinsa will be the first and only BTK inhibitor approved for follicular lymphoma. ...