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RSS FeedPosted by Michael Wonder on 26 Apr 2023
European Medicines Agency validates marketing authorisation application for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer
25 April 2023 - Regulatory submission based on pivotal data from Part 1 of the RUBY Phase 3 trial. ...
Posted by Michael Wonder on 24 Apr 2023
Janssen marks first approval worldwide for Akeega (niraparib and abiraterone acetate dual action tablet) with EC authorisation for the treatment of patients with metastatic castration resistant prostate cancer with BRCA1/2 mutations
21 April 2023 - Approval for Akeega is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision ...
Posted by Michael Wonder on 17 Apr 2023
Regulatory applications accepted across three regions globally for Abecma for earlier use in adults with triple-class exposed relapsed and/or refractory multiple myeloma
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
Posted by Michael Wonder on 02 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
31 March 2023 - Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier ...
Posted by Michael Wonder on 29 Mar 2023
Libtayo (cemiplimab) in combination with chemotherapy approved by European Commission for the first-line treatment of advanced PD-L1 positive non-small-cell lung cancer
29 March 2023 - Approval marks second first-line indication in non-small-cell lung cancer and fifth indication for Libtayo in the ...
Posted by Michael Wonder on 27 Mar 2023
EMA validates marketing authorisation application for Henlius' Hansizhuang (serplulimab)
23 March 2023 - Hansizhuang (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer. ...
Posted by Michael Wonder on 03 Mar 2023
Nubeqa (darolutamide) receives EU approval for additional indication in prostate cancer
1 March 2023 - Approval is based on Phase 3 ARASENS trial data. ...
Posted by Michael Wonder on 28 Feb 2023
US FDA accepts Bristol Myers Squibb’s supplemental biologics license application and EMA validates application for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
28 February 2023 - The applications are based on results from the Phase 3 CheckMate-76K trial, in which Opdivo demonstrated a ...
Posted by Michael Wonder on 26 Feb 2023
Servier receives a positive CHMP opinion for Tibsovo in IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma patients
24 February 2023 - The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in ...
Posted 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 ...