Blog
RSS FeedPosted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus chemotherapy for first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
25 February 2022 - Recommendation based on positive results from the Phase 3 CheckMate -648 trial, in which the combination demonstrated ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
25 February 2022 - Recommendation based on results from the Phase 3 CheckMate -648 trial, in which the immunotherapy combination demonstrated ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) as adjuvant treatment for patients with radically resected, high-risk muscle-invasive urothelial carcinoma with tumour cell PD-L1 expression ≥1%
25 February 2022 - Recommendation based on results from the Phase 3 CheckMate-274 trial, in which Opdivo significantly reduced patients’ risk ...
Posted by Michael Wonder on 25 Feb 2022
New medicine for rare type of eye cancer
25 February 2022 - EMA has recommended granting a marketing authorisation in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy ...
Posted by Michael Wonder on 22 Feb 2022
BeiGene announces European Medicines Agency acceptance of applications for Brukinsa (zanubrutinib) in chronic lymphocytic leukaemia and marginal zone lymphoma
22 February 2022 - The CLL filing is supported by two global Phase 3 trials of Brukinsa in chronic lymphocytic leukaemia ...
Posted by Michael Wonder on 18 Feb 2022
Sandoz launches generic lenalidomide in 19 countries across Europe, expanding access to essential oncology medicine
18 February 2022 - Cost savings from Lenalidomide Sandoz can expand treatment options for patients with haemato-oncology conditions. ...
Posted by Michael Wonder on 18 Feb 2022
European Commission approves Tepmetko (tepotinib) for patients with advanced NSCLC with METex14 skipping alterations
18 February 2022 - Approval is based on Phase II results from VISION, the largest interventional study to date of patients ...
Posted by Michael Wonder on 02 Feb 2022
New order: European cancer coalition calls for cancer treatment overhaul
2 February 2022 - Coalition urges reformation of EU wide drug research and development to drive treatment optimisation ...
Posted by Michael Wonder on 01 Feb 2022
Janssen submits marketing authorisation application to the EMA seeking approval of bispecific antibody teclistamab for the treatment of patients with relapsed or refractory multiple myeloma
31 January 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application ...
Posted by Michael Wonder on 30 Jan 2022
European Commission approves Lorviqua (lorlatinib) as a first-line treatment for ALK positive advanced lung cancer
28 January 2022 - Approval based on results from Phase 3 CROWN trial, showing Lorviqua reduced risk of disease progression ...
Posted 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 ...