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RSS FeedPosted by Michael Wonder on 17 Nov 2018
Janssen receives positive CHMP opinion for Erleada (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease
16 November 2018 - Approval is based on Phase 3 SPARTAN clinical study data which showed apalutamide decreased the risk of ...
Posted by Michael Wonder on 16 Nov 2018
Novartis receives positive CHMP opinion to expand Kisqali combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer
16 November 2018 - Kisqali is the CDK4/6 inhibitor with the largest body of first-line evidence demonstrating consistent, superior and sustained ...
Posted by Michael Wonder on 16 Nov 2018
European Commission approves Ipsen’s Cabometyx (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib
15 November 2018 - Ipsen today announced that the European Commission has approved Cabometyx (cabozantinib) 20 mg, 40 mg, 60 mg ...
Posted by Michael Wonder on 06 Nov 2018
Sankyo’s FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
5 November 2018 - Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD ...
Posted by Michael Wonder on 01 Nov 2018
AbbVie receives European Commission approval of Venclyxto (venetoclax) plus rituximab for the treatment of patients with chronic lymphocytic leukaemia who have received at least one prior therapy
1 November 2018 - The approval is based on the MURANO Phase 3 clinical trial, in which Venclyxto plus rituximab reduced ...
Posted by Michael Wonder on 30 Oct 2018
Astellas receives European approval for Xtandi (enzalutamide) for adult men with high-risk non-metastatic castration-resistant prostate cancer
29 October 2018 - Results from the PROSPER trial show a median metastasis-free survival of 36.6 months for enzalutamide plus androgen ...
Posted by Michael Wonder on 20 Oct 2018
Bristol-Myers Squibb provides update on the ongoing regulatory review of Opdivo plus low dose Yervoy in first-line lung cancer patients with tumour mutational burden ≥10 mut/Mb
19 October 2018 - New analysis submitted to U.S. FDA constitutes a major amendment to the Company’s supplemental biologics license application. ...
Posted by Michael Wonder on 03 Oct 2018
EU nod for Lilly’s new breast cancer drug
3 October 2018 - Eli Lilly’s CDK 4 and 6 inhibitor Verzenios has been approved in Europe for the treatment ...
Posted by Michael Wonder on 25 Sep 2018
European Commission approves Imfinzi for locally-advanced, unresectable NSCLC
24 September 2018 - Phase III PACIFIC trial demonstrated compelling overall survival benefit and progression-free survival of more than 11 ...
Posted by Michael Wonder on 25 Sep 2018
Astellas receives positive CHMP opinion for Xtandi (enzalutamide) for adult men with high-risk non-metastatic castration-resistant prostate cancer
25 September 2018 - Results from the PROSPER trial show a median metastasis-free survival of 36.6 months for enzalutamide plus androgen ...
Posted by Michael Wonder on 24 Sep 2018
Takeda receives positive CHMP opinion recommending Alunbrig (brigatinib) for the treatment of ALK+ non-small cell lung cancer in patients previously treated with crizotinib
21 September 2018 - Opinion based on pivotal Phase 2 ALTA trial, in which Alunbrig demonstrated an objective response rate of ...
Posted by Michael Wonder on 24 Sep 2018
Ipsen receives positive CHMP opinion for Cabometyx (cabozantinib) for the second-line treatment of patients with hepatocellular carcinoma
21 September 2018 - Ipsen announced today that the CHMP, the scientific committee of the EMA), provided a positive opinion for ...
Posted by Michael Wonder on 22 Sep 2018
AbbVie receives positive CHMP opinion for a novel, chemotherapy-free combination of Venclyxto (venetoclax) with rituximab as a treatment with a fixed duration for patients with chronic lymphocytic leukaemia who have received at least one prior therapy
21 September 2018 - The positive opinion is based on the MURANO Phase 3 clinical trial, in which Venclyxto plus ...
Posted by Michael Wonder on 21 Sep 2018
Pierre Fabre receives EU approval for Braftovi (encorafenib) + Mektovi (binimetinib) in adult patients with advanced BRAF-mutant melanoma
20 September 2018 - EU approval is based on Phase 3 COLUMBUS trial that demonstrated 14.9 months median progression-free survival and ...
Posted by Michael Wonder on 18 Sep 2018
EMA validates Bristol-Myers Squibb’s application for Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone in patients with multiple myeloma
18 September 2018 - Bristol-Myers Squibb today announced that the EMA has validated the Company’s type II variation application for ...