Blog
RSS FeedPosted 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% ...
Posted by Michael Wonder on 22 Jun 2022
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease
22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...
Posted by Michael Wonder on 21 Jun 2022
European Medicines Agency validates Bristol Myers Squibb’s application for CAR T-cell therapy Breyanzi in relapsed or refractory large B-cell lymphoma after first-line therapy
20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...
Posted by Michael Wonder on 08 Jun 2022
European Commission approves Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma
8 June 2022 - Approval is based on the phase I/II GO29781 study, where Lunsumio induced high complete response rates, with ...
Posted by Michael Wonder on 27 May 2022
Carvykti (ciltacabtagene autoleucel) granted conditional approval by the European Commission for the treatment of patients with relapsed and refractory multiple myeloma
26 May 2022 - The approval is based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
Posted by Michael Wonder on 26 May 2022
European Commission approves Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early stage triple negative breast cancer at high risk of recurrence
24 May 2022 - Approval based on event-free survival benefit demonstrated in Phase 3 KEYNOTE-522 trial. ...
Posted by Michael Wonder on 26 May 2022
Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
25 May 2022 - Approval is based on pivotal data from the Phase 3 POLARIX study, where Polivy plus R-CHP significantly ...
Posted by Michael Wonder on 21 May 2022
Karyopharm and Menarini Group receive positive CHMP opinion for Nexpovio (selinexor) for the treatment of patients with refractory multiple myeloma
20 May 2022 - European Commission decision anticipated within approximately 60 days. ...
Posted by Michael Wonder on 20 May 2022
Mirati Therapeutics submits marketing authorisation application to the European Medicines Agency for investigational adagrasib as a treatment for previously treated KRASG12C mutated non-small-cell lung cancer
19 May 2022 - Submission follows the U.S. FDA acceptance of the adagrasib new drug application for the same indication ...
Posted by Michael Wonder on 04 May 2022
Novartis Kymriah receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma
4 May 2022 - Approval for relapsed or refractory follicular lymphoma is the third indication for Kymriah in the EU ...
Posted by Michael Wonder on 04 May 2022
European Commission approves Cabometyx as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer
3 May 2022 - Approval based on data from the COSMIC-311 Phase 3 trial, in which Cabometyx (cabozantinib) demonstrated a 78% ...
Posted by Michael Wonder on 02 May 2022
Myovant Sciences announces European Commission approval for Orgovyx (relugolix) for the treatment of advanced hormone sensitive prostate cancer
29 April 2022 - Myovant expects to secure European commercialisation partner ahead of anticipated launches. ...
Posted by Michael Wonder on 28 Apr 2022
Janssen submits marketing authorisation application to EMA seeking approval of niraparib and abiraterone acetate dual action tablet plus prednisone for the treatment of patients with HRR gene mutated metastatic castration resistant prostate cancer
28 April 2022 - The submission to the EMA is based on results from the Phase 3 MAGNITUDE study evaluating niraparib ...
Posted by Michael Wonder on 24 Apr 2022
CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment for a subset of people with early-stage non-small-cell lung cancer
22 April 2022 - In the Phase III IMpower010 trial, adjuvant Tecentriq reduced the risk of disease recurrence or death by ...
Posted by Michael Wonder on 24 Apr 2022
Novartis receives positive CHMP opinion for Tabrecta for patients with METex14 advanced non-small-cell lung cancer
22 April 2022 - Opinion based on Phase 2 GEOMETRY mono-1 study showing an overall response rate (ORR) of 51.6% ...