Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2018
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma
29 June 2018 - First and only PD-1 agent to receive positive CHMP opinion in the adjuvant setting. ...
Posted by Michael Wonder on 30 Jun 2018
Novartis receives positive CHMP opinion for Kymriah for treating two aggressive blood cancers, marking important medical advance for patients in Europe
29 June 2018 - First CHMP opinion for a CAR-T cell therapy in two distinct indications - DLBCL in adults ...
Posted by Michael Wonder on 27 Jun 2018
Puma Biotechnology announces results of CHMP re-examination of MAA for neratinib for extended adjuvant treatment of HER2 positive early stage breast cancer
26 June 2018 - Puma Biotechnology announced that the CHMP of the EMA has adopted a positive trend vote recommending the ...
Posted by Michael Wonder on 11 Jun 2018
The EU approves Tagrisso for first-line treatment of EGFR-mutated non-small cell lung cancer
8 June 2018 - First-line Tagrisso offers a potential new standard of care. ...
Posted by Michael Wonder on 07 Jun 2018
U.S. FDA and EMA accept regulatory submissions for review of tazaloparib for metastatic breast cancer patients with an inherited BRCA mutation
7 June 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 04 Jun 2018
Clovis Oncology submits application to EMA to expand use of Rubraca (rucaparib) to include maintenance treatment for women with recurrent ovarian cancer
4 June 2018 - Submission based on positive phase 3 ARIEL3 clinical trial in which rucaparib significantly improved PFS in all ...
Posted by Michael Wonder on 29 May 2018
Clovis Oncology announces European Commission authorisation of Rubraca (rucaparib) for women with recurrent ovarian cancer
29 May 2018 - First PARP inhibitor licensed for ovarian treatment indication in the EU. ...
Posted by Michael Wonder on 17 May 2018
EU OKs first-line use of Ipsen’s Cabometyx
17 May 2018 - The European Commission has approved Ipsen/Exelixis’ Cabometyx for the first-line treatment of adults with advanced renal ...
Posted by Michael Wonder on 08 May 2018
Lynparza tablets receive EU approval for the treatment of platinum-sensitive relapsed ovarian cancer
8 May 2018 - New formulation reduces dosing to two tablets twice daily. ...
Posted by Michael Wonder on 30 Apr 2018
Tagrisso receives positive EU CHMP opinion for first-line treatment of EGFR-mutated non-small cell lung cancer
27 April 2018 - Recommendation based on FLAURA trial data showing unprecedented median progression-free survival of 18.9 months for Tagrisso ...
Posted by Michael Wonder on 25 Apr 2018
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) four-week dosing schedule for advanced melanoma and previously treated renal cell carcinoma
25 April 2018 - Opdivo also now approved for two-week flat dose option with 30 minute infusions across all approved monotherapy ...
Posted by Michael Wonder on 23 Apr 2018
EMA validates Type II variation for Merck’s Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy as first-line therapy in metastatic non-squamous NSCLC, based on Phase 3 KEYNOTE-189 trial
23 April 2018 - Merck today announced that following validation by the EMA, the centralised review process has begun for the ...
Posted by Michael Wonder on 23 Apr 2018
Mylotarg approved in the EU for the treatment of previously untreated, de novo, CD33-positive acute myeloid leukaemia in combination with chemotherapy
23 April 2018 - Pfizer today announced that the European Commission has approved Mylotarg (gemtuzumab ozogamicin) in combination with daunorubicin and ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations
4 April 2018 - FDA priority review granted for U.S. new drug application. ...
Posted by Michael Wonder on 03 Apr 2018
EMA accepts regulatory submission for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer
3 April 2018 - If approved, AstraZeneca and MSD’s Lynparza would be the first PARP inhibitor to treat patients with breast ...