Blog
RSS FeedPosted by Michael Wonder on 30 Jan 2022
Blueprint Medicines' Ayvakyt (avapritinib) receives positive CHMP opinion for the treatment of adults with advanced systemic mastocytosis
28 January 2022 - Positive opinion based on results from two clinical trials that comprise the largest clinical trial dataset in ...
Posted by Michael Wonder on 29 Jan 2022
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B
28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...
Posted by Michael Wonder on 19 Jan 2022
FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC
19 January 2022 - Regulatory filing recently submitted in the European Union. ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Lumykras (sotorasib) for patients with KRAS G12C mutated advanced non-small cell lung cancer
10 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumykras ...
Posted by Michael Wonder on 28 Dec 2021
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
28 December 2021 - Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression ...
Posted by Michael Wonder on 22 Dec 2021
Helsinn Group announces EMA acceptance for review of the marketing authorisation application for infigratinib for patients with cholangiocarcinoma with fibroblast growth factor receptor 2 fusions or rearrangements
21 December 2021 - Helsinn today announced that the EMA accepted for review the Company’s marketing authorisation application for infigratinib for ...
Posted by Michael Wonder on 18 Dec 2021
Astellas and Seagen receive positive CHMP opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
17 December 2021 - If approved, PADCEV would be the first medicine for patients in the EU who have received prior ...
Posted by Michael Wonder on 18 Dec 2021
Tepmetko (tepotinib) receives positive CHMP opinion for patients with advanced NSCLC with METex14 skipping alterations
17 December 2021 - Tepmetko is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe ...
Posted by Michael Wonder on 13 Dec 2021
Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced non-small-cell lung cancer with EGFR exon 20 insertion mutations
10 December 2021 - Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced ...
Posted by Michael Wonder on 09 Dec 2021
Consensus lacking on ‘value’ for new anti-cancer drugs
8 December 2021 - The high price tag of new anticancer drugs has fuelled debate about the value of these treatments, ...
Posted by Michael Wonder on 04 Dec 2021
Janssen seeks approval of Imbruvica (ibrutinib) in a fixed duration regimen for patients with untreated chronic lymphocytic leukaemia
30 November 2021 - Application based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the safety ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for patients with certain types of endometrial carcinoma
29 November 2021 - Approval based on KEYNOTE-775/Study 309 results demonstrating statistically significant improvements in overall survival and progression-free survival ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) as first-line treatment for adult patients with advanced renal cell carcinoma
29 November 2021 - Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of ...
Posted by Michael Wonder on 24 Nov 2021
Trodelvy (sacituzumab govitecan) granted European Commission marketing authorisation for treatment of metastatic triple negative breast cancer in second line
23 November 2021 - Marketing authorisation based on Phase 3 ASCENT study showing Trodelvy significantly improved overall survival versus physician’s choice ...
Posted by Michael Wonder on 22 Nov 2021
Deciphera receives European Commission approval of Qinlock for the treatment of fourth-line gastro-intestinal stromal tumour
22 November 2021 - Qinlock significantly reduced the risk of disease progression or death by 85% and showed clinically meaningful overall ...