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RSS FeedPosted by Michael Wonder on 29 Jan 2019
Janssen announces European Commission approval of Erleada (apalutamide) for non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease
16 January 2019 - Phase 3 SPARTAN data served as basis for approval, which showed apalutamide decreased the risk of distant ...
Posted by Michael Wonder on 25 Jan 2019
Clovis Oncology announces European Commission authorisation of Rubraca (rucaparib) tablets as maintenance treatment for women with relapsed ovarian cancer
24 January 2019 - Positive data from the phase 3 ARIEL3 clinical trial supported this expanded indication making Rubraca available to ...
Posted by Michael Wonder on 23 Jan 2019
No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life
23 January 2019 - Preliminary results from the ANNOUNCE study show that Lartruvo (olaratumab) in combination with doxorubicin is not ...
Posted by Michael Wonder on 23 Jan 2019
European Commission approves Blincyto (blinatumomab) in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor acute lymphoblastic leukaemia
22 January 2019 - Approval based on data from the Phase 2 BLAST study, the largest prospective trial in minimal residual ...
Posted by Michael Wonder on 14 Jan 2019
European Commission approves Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma
14 January 2019 - Approval based on results from Phase 3 CheckMate-214 trial. ...
Posted by Michael Wonder on 08 Jan 2019
Stemline Therapeutics announces submission of European marketing authorisation application for Elzonris
7 January 2019 - Stemline Therapeutics announced today that it has submitted the marketing authorisation application for Elzonris (tagraxofusp) to ...
Posted by Michael Wonder on 21 Dec 2018
Janssen announces European Commission approval of Darzalex (daratumumab) split dosing regimen
20 December 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission has granted ...
Posted by Michael Wonder on 20 Dec 2018
Biosimilar trastuzumab co-developed by Biocon receives approval in the EU
19 December 2018 - Ogivri, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, has been approved in the EU. ...
Posted by Michael Wonder on 18 Dec 2018
European Commission approves Merck’s Keytruda (pembrolizumab) as adjuvant therapy for adults with resected Stage III melanoma
17 December 2018 - First approval for Keytruda in an adjuvant setting in the European Union. ...
Posted by Michael Wonder on 17 Dec 2018
Bristol-Myers Squibb receives positive CHMP opinion recommending Sprycel (dasatinib) for paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia
17 December 2018 - Bristol-Myers Squibb today announced that the CHMP of the EMA has recommended the expanded approval of ...
Posted by Michael Wonder on 17 Dec 2018
CHMP grants positive opinion for new indication of Clovis Oncology’s Rubraca (rucaparib) tablets as maintenance treatment for women with relapsed ovarian cancer
13 December 2018 - European Commission marketing authorisation is anticipated Q1 2019. ...
Posted by Michael Wonder on 17 Dec 2018
Takeda receives positive CHMP opinion for Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30 positive Stage IV Hodgkin lymphoma in combination with AVD
15 December 2018 - If authorized in Europe, Adcetris in combination with AVD (Adriamycin, vinblastine and dacarbazine) will be the ...
Posted by Michael Wonder on 28 Nov 2018
European Commission approves Alunbrig (brigatinib) for ALK positive, non-small cell lung cancer in patients previously treated with crizotinib, advancing treatment paradigm in Europe
28 November 2018 - Alunbrig demonstrated unprecedented median progression-free survival of 16.7 months and overall survival of 34.1 months in the ...
Posted by Michael Wonder on 21 Nov 2018
Roche pulls EU Tecentriq/Avastin filing in kidney cancer
19 November 2018 - Another setback for Roche, but CHMP changes its mind on Opdivo/Yervoy. ...
Posted by Michael Wonder on 21 Nov 2018
Janssen seeks expanded use of Imbruvica (ibrutinib) in two indications in Europe
14 November 2018 - Applications submitted to the EMA for new combinations in adult patients with chronic lymphocytic leukaemia and Waldenström's ...