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RSS FeedPosted by Michael Wonder on 19 Jun 2020
BeiGene announces European Medicines Agency acceptance of its marketing authorisation application for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinaemia
18 June 2020 - BeiGene today announced that its marketing authorisation application for Brukinsa (zanubrutinib) for the treatment of patients with ...
Posted by Michael Wonder on 08 Jun 2020
NICE publishes appraisal consultation for isatuximab in combination with pomalidomide and dexamethasone for treating patients with relapsed and refractory multiple myeloma
4 June 2020 - The appraisal committee has considered the evidence submitted by the company and the views of non-company consultees ...
Posted by Michael Wonder on 04 Jun 2020
Pierre Fabre receives European approval for Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAF V600E-mutant metastatic colorectal cancer
3 June 2020 - European approval is based on the Phase 3 BEACON CRC trial that demonstrated a significant improvement in ...
Posted by Michael Wonder on 02 Jun 2020
European Commission approves Sarclisa (isatuximab) for adults with relapsed and refractory multiple myeloma
2 June 2020 - EC approval based on data from first randomised Phase 3 trial (ICARIA-MM) to report results evaluating an ...
Posted by Michael Wonder on 02 Jun 2020
Lynparza recommended for approval in EU by CHMP for BRCA mutated metastatic pancreatic cancer
1 June 2020 - Only PARP inhibitor to demonstrate patient benefit in a Phase III trial in this setting. ...
Posted by Michael Wonder on 31 May 2020
CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer
29 May 2020 - Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, ...
Posted by Michael Wonder on 31 May 2020
Novartis Piqray receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation
29 May 2020 - Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast ...
Posted by Michael Wonder on 22 May 2020
EMA validates Bristol Myers Squibb’s applications for idecabtagene vicleucel and CC-486
22 May 2020 - Applications based on positive results from pivotal KarMMa study in relapsed and refractory multiple myeloma and QUAZAR-AML-001 ...
Posted by Michael Wonder on 15 May 2020
Seattle Genetics announces Adcetris (brentuximab vedotin) receives European Commission approval for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma
14 May 2020 - Approval based on positive ECHELON-2 phase 3 trial results demonstrating superior progression-free survival and overall survival with ...
Posted by Michael Wonder on 03 May 2020
Pierre Fabre receives positive CHMP opinion for Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAF V600E-mutant metastatic colorectal cancer
1 May 2020 - If approved, the combination has the potential to be the first targeted regimen specifically for patients with ...
Posted by Michael Wonder on 08 Apr 2020
Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer
8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial. ...
Posted by Michael Wonder on 07 Apr 2020
European Commission approves Takeda’s Alunbrig (brigatinib) as a first-line treatment for ALK+ NSCLC
6 April 2020 - Approval based on positive results from the Phase 3 ALTA-1L trial showing Alunbrig demonstrated superior overall and ...
Posted by Michael Wonder on 31 Mar 2020
Nubeqa (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer
30 March 2020 - Approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival ...
Posted by Michael Wonder on 27 Mar 2020
Sanofi receives positive CHMP opinion for Sarclisa (isatuximab) for the treatment of relapsed and refractory multiple myeloma
27 March 2020 - Positive CHMP opinion based on data from ICARIA-MM, the first randomised Phase 3 trial to evaluate an ...
Posted by Michael Wonder on 12 Mar 2020
AbbVie receives European Commission approval of Venclyxto combination regimen for patients with previously-untreated chronic lymphocytic leukaemia
12 March 2020 - Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with ...