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RSS FeedPosted by Michael Wonder on 07 Sep 2019
European Commission approves Roche’s new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer
6 September 2019 - Decision based on data showing that the Tecentriq plus chemotherapy combination demonstrated a significant overall survival ...
Posted by Michael Wonder on 07 Sep 2019
European Commission approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer
6 September 2019 - Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved by ...
Posted by Michael Wonder on 07 Sep 2019
Lonsurf (trifluridine/tipiracil) receives marketing authorisation in Europe for patients with previously treated metastatic gastric cancer
6 September 2019 - Servier and its partner Taiho Pharmaceutical announced today that the European Commission has approved the use ...
Posted by Michael Wonder on 05 Sep 2019
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
4 September 2019 - European approval based on KEYNOTE-426 trial results demonstrating significant improvement in overall survival with Keytruda in combination ...
Posted by Michael Wonder on 29 Aug 2019
European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer
29 August 2019 - Approval based on the Phase III IMpassion130 study, which showed that the combination improved outcomes in people ...
Posted by Michael Wonder on 27 Aug 2019
European Commission approves Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed and refractory multiple myeloma
27 August 2019 - Median progression-free survival and overall response rate doubled among patients receiving EPd compared to pomalidomide and low-dose ...
Posted by Michael Wonder on 14 Aug 2019
Janssen announces European Commission approval of Imbruvica (ibrutinib) for expanded use in two indications
13 August 2019 - Decision represents the fifth European approval in five years. ...
Posted by Michael Wonder on 29 Jul 2019
Lonsurf (trifluridine/tipiracil) receives positive opinion from CHMP in the EU for patients with previously treated metastatic gastric cancer
26 July 2019 - Servier and its partner Taiho Pharmaceutical announced today that the CHMP of the EMA has issued a ...
Posted by Michael Wonder on 29 Jul 2019
CHMP recommends EU approval of Roche’s Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer
26 July 2019 - Decision based on results from first Phase III study to show a cancer immunotherapy-based combination significantly ...
Posted by Michael Wonder on 29 Jul 2019
Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer
26 July 2019 - Decision based on data showing that the Tecentriq plus chemotherapy combination demonstrated a significant overall survival and ...
Posted by Michael Wonder on 26 Jul 2019
Bayer receives positive CHMP opinion for precision oncology treatment larotrectinib with first ever tumour-agnostic indication in in Europe
26 July 2019 - CHMP opinion is based on pooled data showing that larotrectinib provides high and durable responses in adult ...
Posted by Michael Wonder on 26 Jul 2019
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone for treatment of patients with relapsed and refractory multiple myeloma
26 July 2019 - Bristol-Myers Squibb today announced that the CHMP of the EMA has adopted a positive opinion on ...
Posted by Michael Wonder on 25 Jul 2019
Astellas announces acceptance by the EMA of a variation application for regulatory review for use of Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer
24 July 2019 - Astellas Pharma announced the acceptance by the EMA of a Type II variation application for regulatory review ...
Posted by Michael Wonder on 20 Jul 2019
Blueprint Medicines announces European Medicines Agency validation of marketing authorisation application for avapritinib for the treatment of PDGFRα D842V mutant GIST and fourth-line GIST
18 July 2019 - Blueprint Medicines Corporation today announced that the EMA has validated the company's marketing authorisation application for avapritinib ...
Posted by Michael Wonder on 20 Jul 2019
Janssen seeks EMA approval for novel subcutaneous formulation of Darzalex (daratumumab)
19 July 2019 - Data supporting the application demonstrated that the investigational subcutaneous formulation improved quality of life, reduced administration time, ...