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RSS FeedPosted by Michael Wonder on 28 Jun 2021
Incyte and MorphoSys announce positive CHMP opinion for tafasitamab in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
25 June 2021 - The positive opinion from the CHMP is based on data from the Phase 2 L-MIND study evaluating ...
Posted by Michael Wonder on 28 Jun 2021
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
25 June 2021 - Recommendation based on positive results from the Phase 3 CheckMate -577 trial in which Opdivo doubled disease-free ...
Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma
25 June 2021 - Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma ...
Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression
25 June 2021 - Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in ...
Posted by Michael Wonder on 27 Jun 2021
Bristol Myers Squibb receives positive CHMP opinion for anti-BCMA CAR T cell therapy Abecma (idecabtagene vicleucel) for relapsed and refractory multiple myeloma
25 June 2021 - Recommendation for approval based on results from pivotal KarMMa study. ...
Posted by Michael Wonder on 22 Jun 2021
Bristol Myers Squibb receives European Commission approval for Onureg (azacitidine tablets) as frontline oral maintenance therapy for adults with acute myeloid leukaemia
18 June 2021 - Onureg is the first and only once daily, frontline oral maintenance therapy in the European Union for ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 10 Jun 2021
Copiktra (duvelisib) receives European Union marketing authorisation for the treatment of relapsed or refractory CLL and refractory FL
9 June 2021 - Secura Bio today announced that on 19 May 2021, the European Medicines Agency granted marketing authorisation for ...
Posted by Michael Wonder on 28 May 2021
Tagrisso approved in the EU for the adjuvant treatment of patients with early stage EGFR mutated lung cancer
28 May 2021 - Approval based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk ...
Posted by Michael Wonder on 25 May 2021
AbbVie receives European Commission approval of Venclyxto (venetoclax) in combination with a hypomethylating agent for patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
25 May 2021 - Venclyxto (venetoclax) in combination with a hypomethylating agent is a new regimen approved by the European ...
Posted by Michael Wonder on 25 May 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for certain patients with oesophageal cancer or HER2 negative gastro-oesophageal junction adenocarcinoma
24 May 2021 - Recommendation based on significant survival benefit demonstrated with Keytruda plus chemotherapy versus chemotherapy in Phase 3 KEYNOTE-590 ...
Posted by Michael Wonder on 24 May 2021
Libtayo (cemiplimab) receives positive CHMP opinion for the treatment in Europe of two advanced cancers
24 May 2021 - CHMP has now issued three positive opinions for Libtayo in advanced cancers. ...
Posted by Michael Wonder on 24 May 2021
Bristol Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for treatment of mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer after prior chemotherapy
21 May 2021 - Application based on positive results from the Phase 2 CheckMate-142 trial demonstrating a durable clinical benefit in ...
Posted by Michael Wonder on 20 May 2021
NICE turns down Janssen's Erleada
20 May 2021 - NICE has published draft guidance rejecting Janssen's Erleada (apalutamide) with androgen deprivation therapy for treating prostate ...
Posted by Michael Wonder on 05 May 2021
Roche’s Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
5 May 2021 - This approval marks Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung ...