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RSS FeedPosted by Michael Wonder on 28 Jun 2024
AbbVie receives positive CHMP opinion for epcoritamab (Tepkinly) for the treatment of adults with relapsed/refractory follicular lymphoma
28 June 2024 - Positive CHMP opinion based on results from the Phase 1/2 EPCORE NHL-1 study. ...
Posted by Michael Wonder on 26 Jun 2024
ExCellThera announces EMA’s acceptance under accelerated assessment of market authorisation application for UM171 cell therapy for patients with haematological malignancies who lack a readily available suitable donor
25 June 2024 - ExCellThera announced today that the market authorisation application for UM171 cell therapy (INN-dorocubicel) has been accepted under ...
Posted by Michael Wonder on 25 Jun 2024
Jemperli (dostarlimab) plus chemotherapy application accepted for review by the EMA to expand use to all patients with primary advanced or recurrent endometrial cancer
24 June 2024 - Regulatory submission supported by statistically significant and clinically meaningful progression-free and overall survival data from Part 1 ...
Posted by Michael Wonder on 22 Jun 2024
Takeda receives approval from European Commission for Fruzaqla in previously treated metastatic colorectal cancer
21 June 2024 - Approval based on results from positive, global, Phase 3 FRESCO-2 trial. ...
Posted by Michael Wonder on 21 Jun 2024
European Medicines Agency validates Bristol Myers Squibb’s application for subcutaneous nivolumab
21 June 2024 - Validation is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation ...
Posted by Michael Wonder on 20 Jun 2024
Truqap plus Faslodex approved in the EU for patients with advanced oestrogen receptor positive breast cancer
20 June 2024 - Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or ...
Posted by Michael Wonder on 10 Jun 2024
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK positive early-stage lung cance
10 June 2024 - Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK ...
Posted by Michael Wonder on 04 Jun 2024
CStone announces European Medicine Agency CHMP recommends approval of Cejemly (sugemalimab, anti-PD-L1) as first-line treatment for NSCLC
1 June 2024 - EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant ...
Posted by Michael Wonder on 03 Jun 2024
Tagrisso with the addition of chemotherapy recommended for approval in the EU by CHMP for patients with EGFR mutated advanced lung cancer
3 June 2024 - Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 03 Jun 2024
Johnson & Johnson submits application to the EMA seeking approval of subcutaneous formulation of Rybrevant (amivantamab) for the treatment of patients with EGFR mutated non-small cell lung cancer
31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...
Posted by Michael Wonder on 29 May 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
29 May 2024 - Approval based on results from CheckMate-901, the first Phase 3 trial in this patient population with an ...
Posted by Michael Wonder on 28 May 2024
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
27 May 2024 - FDA priority review granted based on positive results from IMROZ Phase 3 study. ...
Posted by Michael Wonder on 06 May 2024
EMA validates Bristol Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer
6 May 2024 - Application based on results from the CheckMate-8HW study, in which Opdivo plus Yervoy demonstrated statistically significant ...
Posted by Michael Wonder on 29 Apr 2024
Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER positive breast cancer
29 April 2024 - Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression ...
Posted by Michael Wonder on 27 Apr 2024
Takeda receives positive CHMP opinion for fruquintinib in previously treated metastatic colorectal cancer
26 April 2024 - If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal ...