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RSS FeedPosted by Michael Wonder on 12 Jan 2024
European Commission approves Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small-cell lung cancer with a KRAS G12C mutation
10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
Posted by Michael Wonder on 10 Jan 2024
European Commission approves Pfizer’s Talzenna in combination with Xtandi for adult patients with metastatic castration resistant prostate cancer
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...
Posted by Michael Wonder on 02 Jan 2024
European Medicines Agency validates Bristol Myers Squibb’s application for repotrectinib for the treatment of locally advanced or metastatic ROS1 positive non-small cell lung cancer and NTRK positive solid tumours
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
Posted by Michael Wonder on 21 Dec 2023
Janssen submits marketing authorisation application to the EMA seeking approval of lazertinib, in combination with Rybrevant (amivantamab), for the first-line treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
Posted by Michael Wonder on 20 Dec 2023
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy for new first-line indications in advanced HER2 negative gastric or GEJ adenocarcinoma in tumours expressing PD-L1 (CPS ≥1) and advanced biliary tract cancer
18 December 2023 - Keytruda now approved for 26 indications in the EU, including seven in gastro-intestinal cancers. ...
Posted by Michael Wonder on 11 Dec 2023
GSK’s Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer
11 December 2023 - European Commission also converts previous conditional approval for Jemperli to full approval as a monotherapy for ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted 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 ...