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RSS FeedPosted 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 ...
Posted by Michael Wonder on 19 Sep 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with marginal zone lymphoma
19 September 2022 - If approved, Brukinsa will be the first and only approved Bruton’s tyrosine kinase inhibitor for marginal zone ...
Posted by Michael Wonder on 19 Sep 2022
Bristol Myers Squibb receives European Commission approval for LAG-3 blocking antibody combination, Opdualag (nivolumab and relatlimab), for the treatment of unresectable or metastatic melanoma with tumour cell PD-L1 expression < 1%
16 September 2022 - In RELATIVITY-047, Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy. ...
Posted by Michael Wonder on 17 Sep 2022
ADC Therapeutics and Sobi announce Zylonta (loncastuximab tesirine) receives positive CHMP opinion in Europe for the treatment of relapsed or refractory diffuse large B-cell lymphoma
16 September 2022 - Approval decision expected in 4Q 2022. ...
Posted by Michael Wonder on 17 Sep 2022
Kite’s CAR T-cell therapy Yescarta first in Europe to receive positive CHMP opinion for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma
16 September 2022 - Positive opinion based on landmark ZUMA-7 study in which 41% of patients demonstrated event-free survival at ...
Posted by Michael Wonder on 13 Sep 2022
Clovis Oncology submits applications for Rubraca label expansion in the US and European Union as first-line maintenance treatment in women with advanced ovarian cancer
13 September 2022 - Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented ...
Posted by Michael Wonder on 30 Aug 2022
EMA announces withdrawal of two submissions for cancer medicines
30 August 2022 - The information is somewhat buried on the EMA website. ...