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RSS FeedPosted by Michael Wonder on 20 Nov 2019
European Commission approves two new regimens of Merck’s Keytruda (pembrolizumab) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma
20 November 2019 - Approval based on significant overall survival findings from Phase 3 KEYNOTE-048 trial. ...
Posted by Michael Wonder on 20 Nov 2019
Genmab announces European marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone in frontline multiple myeloma
19 November 2019 - Approval based on data from Phase III MAIA study. ...
Posted by Michael Wonder on 17 Nov 2019
CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment
15 November 2019 - Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant ...
Posted by Michael Wonder on 17 Nov 2019
CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma
15 November 2019 - First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells. ...
Posted by Michael Wonder on 28 Oct 2019
European Commission approves Bavencio (avelumab) plus axitinib combination for first-line treatment of patients with advanced renal cell carcinoma
28 October 2019 - EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with Bavencio ...
Posted by Michael Wonder on 26 Oct 2019
European Commission approves Astellas’ Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
25 October 2019 - Approval follows accelerated assessment, orphan designation by European Medicines Agency. ...
Posted by Michael Wonder on 24 Oct 2019
European Commission approves Opdivo (nivolumab) four week dosing schedule for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
24 October 2019 - Bristol-Myers Squibb today announced that the European Commission has approved Opdivo (nivolumab) flat dosing schedule of ...
Posted by Michael Wonder on 21 Oct 2019
Daiichi Sankyo receives negative CHMP opinion for FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
18 October 2019 - Global clinical development program of quizartinib continues with focus on newly-diagnosed FLT3-ITD AML with enrolment completed into ...
Posted by Michael Wonder on 18 Oct 2019
Merck receives positive EU CHMP opinion for two new regimens of Keytruda (pembrolizumab) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma
18 October 2019 - Opinion supports use of Keytruda, as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, in patients ...
Posted by Michael Wonder on 24 Sep 2019
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) four week dosing schedule for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
24 September 2019 - Bristol-Myers Squibb today announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab) ...
Posted by Michael Wonder on 23 Sep 2019
Vitrakvi (larotrectinib) receives first tumour agnostic approval in EU
23 September 2019 - Precision oncology treatment Vitrakvi (larotrectinib) approved for the treatment of adults and children with locally advanced or ...
Posted by Michael Wonder on 21 Sep 2019
Astellas receives positive CHMP opinion for Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
20 September 2019 - If approved by the European Commission, gilteritinib would represent one of the few advances in Europe for ...
Posted by Michael Wonder on 21 Sep 2019
CHMP adopts positive opinion for Bavencio (avelumab) plus axitinib for first-line treatment of patients with advanced renal cell carcinoma
20 September 2019 - Opinion based on Phase III data showing combination lowered risk of disease progression or death by 31% ...
Posted by Michael Wonder on 19 Sep 2019
Flawed evidence underpins approval of new cancer drugs
18 September 2019 - We must raise the bar to ensure real benefits for patients ...
Posted by Michael Wonder on 19 Sep 2019
Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis
18 September 2019 - In this study, the investigators examined the characteristics of randomised controlled trials that supported approval of cancer ...