Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for LAG-3-blocking antibody combination Opdualag (nivolumab and relatlimab) for treatment of patients with unresectable or metastatic melanoma
22 July 2022 - Recommendation based on results from the Phase 2/3 RELATIVITY-047 trial, in which the fixed-dose combination of the ...
Posted by Michael Wonder on 23 Jul 2022
New medicine for multiple myeloma patients with limited treatment options
22 July 2022 - The EMA has recommended a conditional marketing authorisation in the European Union for Tecvayli (teclistamab) for ...
Posted by Michael Wonder on 22 Jul 2022
EMA recommends restricting use of cancer medicine Rubraca
22 July 2022 - EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used ...
Posted by Michael Wonder on 21 Jul 2022
Karyopharm and Menarini receive full marketing authorisation from the European Commission for Nexpovio (selinexor) for the treatment of patients with multiple myeloma after at least one prior therapy
21 July 2022 - Based on Results from Phase 3 BOSTON Study, Marketing Authorisation Expands Multiple Myeloma Indication. ...
Posted by Michael Wonder on 19 Jul 2022
Genmab announces that AbbVie will submit marketing authorisation application to EMA for epcoritamab for the treatment of relapsed/refractory diffuse large B-cell lymphoma
18 July 2022 - Genmab today announced that AbbVie will submit a conditional marketing authorisation application with the EMA for ...
Posted by Michael Wonder on 19 Jul 2022
Enhertu approved in the EU for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2 based regimens
19 July 2022 - Based on groundbreaking DESTINY-Breast03 results in which Enhertu demonstrated a 72% reduction in the risk of ...
Posted by Michael Wonder on 18 Jul 2022
EMA validates marketing authorisation application for trastuzumab duocarmazine (SYD985) in HER2 positive metastatic breast cancer
18 July 2022 - Submission follows positive results of Phase 3 TULIP trial. ...
Posted by Michael Wonder on 28 Jun 2022
Janssen receives positive CHMP opinion for Imbruvica (ibrutinib) in a fixed-duration combination regimen for adult patients with previously untreated chronic lymphocytic leukaemia
24 June 2022 - The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated ...
Posted by Michael Wonder on 27 Jun 2022
European Commission approves Keytruda (pembrolizumab) as adjuvant treatment for adult and adolescent patients (≥12 years of age) with stage IIB or IIC melanoma following complete resection
24 June 2022 - Approval based on recurrence-free survival and distant metastasis-free survival benefit demonstrated by KEYTRUDA in the Phase 3 ...
Posted by Michael Wonder on 27 Jun 2022
Lynparza recommended for approval in the EU by CHMP as adjuvant treatment for patients with germline BRCA mutated HER2 negative high risk early breast cancer
27 June 2022 - First PARP inhibitor to improve overall survival in early-stage breast cancer. ...
Posted by Michael Wonder on 27 Jun 2022
Trastuzumab deruxtecan recommended for approval in the EU by CHMP for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
27 June 2022 - Recommendation based on DESTINY-Breast03 trial results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced the risk ...
Posted by Michael Wonder on 26 Jun 2022
CHMP issues a positive opinion recommending full approval of Oncopeptides Pepaxti in EU for patients with triple class refractory multiple myeloma
23 June 2022 - Oncopeptides today announces that the EMA's CHMP, has unanimously adopted a positive opinion recommending a full marketing ...
Posted by Michael Wonder on 25 Jun 2022
Novartis receives positive CHMP opinion for Scemblix, a novel treatment for adult patients with chronic myeloid leukaemia
24 June 2022 - ...
Posted by Michael Wonder on 24 Jun 2022
BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer
23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...
Posted by Michael Wonder on 23 Jun 2022
Novartis receives European Commission approval for Tabrecta for the treatment of METex14 skipping advanced non-small cell lung cancer
22 June 2022 - Approval based on the Phase II GEOMETRY mono-1 trial, which showed an overall response rate of 51.6% ...