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RSS FeedPosted by Michael Wonder on 24 Feb 2023
Libtayo (cemiplimab) in combination with chemotherapy receives positive CHMP opinion for the treatment of advanced PD-L1 positive non-small cell lung cancer
24 February 2023 - Recommendation based on a Phase 3 trial demonstrating superior survival outcomes for Libtayo plus chemotherapy compared to ...
Posted by Michael Wonder on 24 Feb 2023
Janssen receives positive CHMP opinion for Akeega (niraparib and abiraterone acetate dual action tablet) plus prednisone or prednisolone for the treatment of adult patients with BRCA1/2 gene mutated metastatic castration resistant prostate cancer
24 February 2023 - The positive CHMP opinion is based on results from the Phase 3 MAGNITUDE study where the ...
Posted by Michael Wonder on 22 Feb 2023
Pfizer’s elranatamab receives FDA and EMA filing acceptance
22 February 2023 - Submissions based on favourable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma. ...
Posted by Michael Wonder on 22 Feb 2023
Calquence tablet formulation approved in the EU for patients with chronic lymphocytic leukaemia
22 February 2023 - Approval based on ELEVATE-PLUS trials which showed bioequivalence and consistent dosing versus current capsule. ...
Posted by Michael Wonder on 22 Feb 2023
Imfinzi plus Imjudo approved in the EU for patients with advanced liver and non-small-cell lung cancers
22 February 2023 - Approvals based on significant survival benefits in HIMALAYA and POSEIDON Phase 3 trials. ...
Posted by Michael Wonder on 27 Jan 2023
CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone sensitive prostate cancer
27 January 2023 - CHMP recommendation is based on Phase 3 data, which demonstrated that darolutamide plus androgen deprivation therapy in ...
Posted by Michael Wonder on 26 Jan 2023
Enhertu approved in the EU as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
26 January 2023 - Approval based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease ...
Posted by Michael Wonder on 04 Jan 2023
Enhertu type II variation application validated by EMA for the treatment of HER2 mutant metastatic non-small-cell lung cancer
4 January 2022 - Submission based on DESTINY-Lung02 and DESTINY-Lung01 Phase 2 trial results which showed Daiichi Sankyo and AstraZeneca’s Enhertu ...
Posted by Michael Wonder on 04 Jan 2023
Janssen submits marketing authorisation application to the European Medicines Agency seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma
3 January 2023 - Janssen today announced the submission of a marketing authorisation application to the EMA seeking approval of ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates marketing authorisation application for Trodelvy (sacituzumab govitecan-hziy) for pre-treated HR+/HER2- metastatic breast cancer
3 January 2023 - Application based on statistically significant and clinically meaningful overall survival and progression-free survival results from the Phase ...
Posted by Michael Wonder on 22 Dec 2022
Zynlonta (loncastuximab tesirine) approved in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma
21 December 2022 - Sobi and ADC Therapeutics today announced that the European Commission has granted conditional marketing authorisation for the ...
Posted by Michael Wonder on 21 Dec 2022
Lynparza in combination with abiraterone approved in the EU as first-line treatment for patients with metastatic castration-resistant prostate cancer
21 December 2022 - First approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent. ...
Posted by Michael Wonder on 21 Dec 2022
Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer
21 December 2022 - Approval based on TOPAZ-1 updated survival results showing Imfinzi combination reduced risk of death by 24% ...
Posted by Michael Wonder on 19 Dec 2022
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low metastatic breast cancer
19 December 2022 - AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2 directed therapy to demonstrate a significant survival ...
Posted by Michael Wonder on 19 Dec 2022
Enhertu approved in the EU for patients with previously treated HER2 positive advanced gastric cancer
19 December 2022 - Based on DESTINY-Gastric02 and DESTINY-Gastric01 where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated clinically meaningful efficacy. ...