Blog
RSS FeedPosted by Michael Wonder on 05 Apr 2022
European Commission approves Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
4 April 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall ...
Posted by Michael Wonder on 31 Mar 2022
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
31 March 2022 - EMA, in collaboration with the European Organisation for Research and Treatment of Cancer, has launched the Cancer ...
Posted by Michael Wonder on 29 Mar 2022
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for resectable non-small-cell lung cancer
29 March 2022 - Application based on CheckMate-816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete ...
Posted by Michael Wonder on 28 Mar 2022
Blueprint Medicines' Ayvakyt (avapritinib) receives European Commission approval for the treatment of adults with advanced systemic mastocytosis
25 March 2022 - Initial commercial launch is planned for Germany immediately following the European Commission approval. ...
Posted by Michael Wonder on 25 Mar 2022
Highlights from the CHMP 21-24 March 2022 meeting
25 March 2022 - The EMA’s CHMP recommended five medicines for approval at its March 2022 meeting. ...
Posted by Michael Wonder on 25 Mar 2022
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) for patients with microsatellite instability-high or mismatch repair deficient tumours in five different types of cancer
25 March 2022 - Recommendation supports use of Keytruda for certain patients with unresectable or metastatic MSI-H/dMMR colorectal, gastric, small ...
Posted by Michael Wonder on 25 Mar 2022
Ipsen receives positive CHMP opinion for Cabometyx in radioactive iodine-refractory differentiated thyroid cancer
25 March 2022 - Recommendation based on data from the COSMIC-311 Phase 3 trial, in which Cabometyx (cabozantinib) demonstrated a 78% ...
Posted by Michael Wonder on 25 Mar 2022
Novartis receives positive CHMP opinion for Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe
25 March 2022 - CHMP opinion based on Phase 2 global ELARA trial demonstrating high response rates in heavily pretreated patients; ...
Posted by Michael Wonder on 25 Mar 2022
CHMP recommends EU approval of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
25 March 2022 - Recommendation is based on pivotal data from the Phase 3 POLARIX trial. ...
Posted by Michael Wonder on 25 Mar 2022
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy, with or without bevacizumab, as treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥1)
25 March 2022 - Opinion granted based on positive results from Phase 3 KEYNOTE-826 trial. ...
Posted by Michael Wonder on 25 Mar 2022
New gene therapy to treat adult patients with multiple myeloma
25 March 2022 - EMA has recommended a conditional marketing authorisation in the European Union for Carvykti (ciltacabtagene autoleucel) for the ...
Posted by Michael Wonder on 11 Mar 2022
Janssen seeks approval of a new indication for Imbruvica (ibrutinib) for use in patients with untreated mantle cell lymphoma
8 March 2022 - Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ...
Posted by Michael Wonder on 10 Mar 2022
Servier submits a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for patients with IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma
10 March 2022 - The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway. ...
Posted by Michael Wonder on 09 Mar 2022
Bayer submits applications in the U.S. and EU for additional indication of Nubeqa (darolutamide)
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New ...
Posted by Michael Wonder on 28 Feb 2022
Astellas and Seagen announce CHMP confirms positive opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
28 February 2022 - Astellas Pharma and Seagen today announced that the CHMP of the EMA has confirmed its previously ...