Blog
RSS FeedPosted by Michael Wonder on 19 Dec 2022
Imfinzi plus Imjudo recommended for approval in the EU by CHMP for the treatment of advanced liver and lung cancers
19 December 2022 - Positive opinions based on significant survival benefit in HIMALAYA and POSEIDON Phase 3 trials. ...
Posted by Michael Wonder on 03 Dec 2022
European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...
Posted by Michael Wonder on 03 Dec 2022
EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer
2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...
Posted by Michael Wonder on 22 Nov 2022
Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy in second-line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumour histology
22 November 2022 - Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or ...
Posted by Michael Wonder on 19 Nov 2022
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of adults with chronic lymphocytic leukaemia
17 November 2022 - Brukinsa is the only Bruton’s tyrosine kinase inhibitor to achieve superiority over ibrutinib in relapsed/refractory chronic lymphocytic ...
Posted by Michael Wonder on 15 Nov 2022
Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic castration-resistant prostate cancer
14 November 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this ...
Posted by Michael Wonder on 15 Nov 2022
Junshi Biosciences announces submission of a marketing authorisation application to the European Medicines Agency for toripalimab
14 November 2022 - The MAA was submitted in the EU for toripalimab seeking indications for the first-line treatment of NPC ...
Posted by Michael Wonder on 15 Nov 2022
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2 positive advanced gastric cancer
14 November 2022 - Based on DESTINY-Gastric02, which showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated clinically meaningful efficacy and DESTINY-Gastric01, which ...
Posted by Michael Wonder on 15 Nov 2022
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer
14 November 2022 - Positive opinion based on TOPAZ-1 Phase 3 trial updated survival results showing Imfinzi combination reduced risk ...
Posted by Michael Wonder on 03 Nov 2022
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of adults with marginal zone lymphoma
2 November 2022 - Brukinsa is the first and only Bruton’s tyrosine kinase inhibitor for marginal zone lymphoma approved in the ...
Posted by Michael Wonder on 18 Oct 2022
Kite’s Yescarta first CAR T-cell therapy to receive European marketing authorisation for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma
17 October 2022 - First treatment in 30 years to improve upon standard care for second-line treatment of DLBCL. ...
Posted by Michael Wonder on 15 Oct 2022
CHMP recommends approval of Atara Biotherapeutics’ Ebvallo (tabelecleucel) for the treatment of Epstein-Barr virus positive post transplant lymphoproliferative disease
14 October 2022 - Ebvallo on track to be the first ever allogeneic T-cell therapy approved. ...
Posted by Michael Wonder on 15 Oct 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with CLL
14 October 2022 - If approved, Brukinsa would be the only BTK inhibitor for chronic lymphocytic leukaemia in the European Union to ...
Posted by Michael Wonder on 14 Oct 2022
Novartis receives positive CHMP opinion for Pluvicto for patients with progressive, PSMA positive metastatic castration-resistant prostate cancer
14 October 2022 - Phase 3 VISION trial showed Pluvicto plus best standard of care significantly improved survival for patients with ...
Posted by Michael Wonder on 14 Oct 2022
Libtayo (cemiplimab) receives positive CHMP opinion recommending approval to treat advanced cervical cancer
14 October 2022 - Recommendation based on a Phase 3 Libtayo trial that was first and only to demonstrate significantly ...