Blog
RSS FeedPosted by Michael Wonder on 08 Apr 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 April 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
Posted by Michael Wonder on 08 Apr 2024
Carvykti is the first and only BCMA targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy
5 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with Carvykti ...
Posted by Michael Wonder on 07 Apr 2024
FDA grants breakthrough therapy designation to sunvozertinib for the first-line treatment of patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations
7 April 2024 - Dizal today announced that the US FDA has granted breakthrough therapy designation to its sunvozertinib as ...
Posted by Michael Wonder on 05 Apr 2024
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2 positive solid tumours
5 April 2024 - Today, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with ...
Posted by Michael Wonder on 05 Apr 2024
US FDA approves Bristol Myers Squibb and 2seventy bio’s Abecma for triple-class exposed relapsed or refractory multiple myeloma after two prior lines of therapy
5 April 2024 - Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% ...
Posted by Michael Wonder on 03 Apr 2024
Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...
Posted by Michael Wonder on 02 Apr 2024
TME Pharma receives US FDA fast track designation for lead asset NOX-A12 in brain cancer
2 April 2024 - Fast track designation for NOX-A12 follows recently announced FDA clearance of investigational new drug application for Phase ...
Posted by Michael Wonder on 02 Apr 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated metastatic HR positive, HER2 negative breast cancer
2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial. ...
Posted by Michael Wonder on 25 Mar 2024
Regeneron provides update on biologics license application for odronextamab
25 March 2024 - Regeneron Pharmaceuticals today announced that the US FDA has issued complete response letters for the biologics license ...
Posted by Michael Wonder on 23 Mar 2024
FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
22 March 2024 - Today, the FDA approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) for adult patients with FRα positive, platinum-resistant epithelial ...
Posted by Michael Wonder on 20 Mar 2024
Phanes Therapeutics' PT886 granted fast track designation for the treatment of patients with metastatic claudin 18.2 positive pancreatic adenocarcinoma by the FDA
20 March 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT886 for the ...
Posted by Michael Wonder on 19 Mar 2024
FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia
19 March 2024 - Today, the FDA granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals) with chemotherapy for adult patients ...
Posted by Michael Wonder on 17 Mar 2024
BeiGene receives FDA approval for Tevimbra for the treatment of advanced or metastatic oesophageal squamous cell carcinoma after prior chemotherapy
14 March 2024 - Results from the global, Phase 3 RATIONALE 302 trial showed Tevimbra prolonged the survival of patients who ...
Posted by Michael Wonder on 16 Mar 2024
ImmVira's oncolytic product MVR-T3011 IT intratumoral injection receives FDA fast track designation for HNSCC treatment
15 March 2024 - ImmVira has recently announced that the US FDA has granted fast track designation for oncolytic virus product ...
Posted by Michael Wonder on 15 Mar 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as the first and only CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
14 March 2024 - In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in ...