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RSS FeedPosted by Michael Wonder on 15 Dec 2020
Imfinzi recommended for approval in the EU by CHMP for less-frequent, fixed-dose use in unresectable non-small cell lung cancer
15 December 2020 - Option would extend dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 14 Dec 2020
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
11 December 2020 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to standard of ...
Posted by Michael Wonder on 14 Dec 2020
Trastuzumab deruxtecan recommended for approval in the EU by CHMP for HER2 positive metastatic breast cancer
14 December 2020 - Recommendation based on positive results from the DESTINY-Breast01 trial, which showed durable responses in patients with ...
Posted by Michael Wonder on 13 Dec 2020
Bristol Myers Squibb receives positive CHMP opinion for Inrebic (fedratinib) for adult patients with newly diagnosed and previously treated myelofibrosis
11 December 2020 - If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in nearly a decade. ...
Posted by Michael Wonder on 13 Dec 2020
Seagen announces positive CHMP opinion for Tukysa (tucatinib) for the treatment of patients with locally advanced or metastatic HER2 positive breast cancer
11 December 2020 - Recommendation for approval in the European Union based on results of pivotal HER2CLIMB trial. ...
Posted by Michael Wonder on 11 Dec 2020
Bavencio (avelumab) receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
11 December 2020 - Merck and Pfizer today announced that the CHMP of the EMA adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 25 Nov 2020
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as second-line treatment for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
24 November 2020 - First immunotherapy to be approved for a gastro-esophageal cancer in the European Union. ...
Posted by Michael Wonder on 19 Nov 2020
NICE recommends another medicine for patients with multiple myeloma
18 November 2020 - Recommended for listing in the Cancer Drugs Fund. ...
Posted by Michael Wonder on 16 Nov 2020
CHMP recommends EU approval of Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2 positive breast cancer
13 November 2020 - Phesgo offers faster and less invasive delivery of standard of care treatment with Perjeta and Herceptin, under ...
Posted by Michael Wonder on 12 Nov 2020
Janssen submits applications in U.S. and EU seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in ...
Posted by Michael Wonder on 09 Nov 2020
Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia
9 November 2020 - Calquence demonstrated superior progression-free survival and favourable tolerability in both previously untreated and relapsed or refractory ...
Posted by Michael Wonder on 07 Nov 2020
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer
6 November 2020 - Approval based on Phase 3 CheckMate-9LA trial results showing superior overall survival in patients with metastatic non-small ...
Posted by Michael Wonder on 05 Nov 2020
Lynparza approved in the EU as first-line maintenance treatment with bevacizumab for HRD positive advanced ovarian cancer
5 November 2020 - Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. ...
Posted by Michael Wonder on 05 Nov 2020
Lynparza approved in the EU for the treatment of BRCA mutated metastatic castration-resistant prostate cancer
5 November 2020 - Only PARP inhibitor to improve overall survival versus new hormonal agent treatments in BRCA mutated metastatic ...
Posted by Michael Wonder on 02 Nov 2020
European Commission approves Zejula (niraparib) as first-line monotherapy maintenance treatment in advanced ovarian cancer
29 October 2020 - Zejula is the first PARP inhibitor approved as monotherapy in the European Union for patients with platinum-responsive ...