Blog
RSS FeedPosted by Michael Wonder on 12 Sep 2018
Are we being misled about precision medicine?
12 September 2018 - Doctors and hospitals love to talk about the cancer patients they’ve saved, and reporters love to write ...
Posted by Michael Wonder on 11 Sep 2018
Minimal residual disease negativity data, a measure of undetectable disease, added to Venclexta (venetoclax tablets) label
11 September 2018 - Minimal residual disease-negativity is defined as having disease at a threshold of less than one chronic lymphocytic ...
Posted by Michael Wonder on 10 Sep 2018
Endocyte announces FDA acceptance of radiographic progression free survival as an alternative primary endpoint of the VISION trial in addition to overall survival
10 September 2018 - Demonstrating benefit in rPFS versus control, with no detriment to OS, sufficient for full approval. ...
Posted by Michael Wonder on 06 Sep 2018
FDA extends review time for Roche’s Tecentriq/Avastin combination
6 September 2018 - US regulators have extended the review period for Roche’s application to market Tecentriq in combination with ...
Posted by Michael Wonder on 05 Sep 2018
Loxo Oncology announces receipt of breakthrough therapy designation from U.S. FDA for LOXO-292
5 September 2018 - Loxo Oncology today announced that the U.S. FDA has granted breakthrough therapy designation to LOXO-292, a ...
Posted by Michael Wonder on 04 Sep 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the treatment of Merkel cell carcinoma, a rare form of skin cancer
4 September 2018 - Application based on data from Phase 2 KEYNOTE-017 trial. ...
Posted by Michael Wonder on 31 Aug 2018
Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review
1 September 2018 - Although patient-reported outcomes, such as health-related quality of life, are important endpoints in randomised controlled trials, there ...
Posted by Michael Wonder on 30 Aug 2018
U.S. Food and Drug Administration accepts Bristol-Myers Squibb’s application for Sprycel (dasatinib) in paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia
30 August 2018 - Application based on results from Phase 2 CA180-372 study. ...
Posted by Michael Wonder on 28 Aug 2018
Cantex Pharmaceuticals receives FDA fast track designation for CX-01 for the treatment of patients over age 60 with newly diagnosed acute myeloid leukaemia
27 August 2018 - Cantex Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for Cantex's lead product ...
Posted by Michael Wonder on 27 Aug 2018
Amgen submits supplemental new drug application for Kyprolis (carfilzomib) once weekly 70 mg/m2 in combination with dexamethasone
27 August 2018 - Filing based on data from Phase 3 head-to-head A.R.R.O.W. study. ...
Posted by Michael Wonder on 27 Aug 2018
AbbVie announces Imbruvica (ibrutinib) plus rituximab approval by U.S. FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia, a rare type of blood cancer
27 August 2018 - Milestone represents ninth FDA approval for Imbruvica in less than five years since its initial approval. ...
Posted by Michael Wonder on 25 Aug 2018
FDA says sponsors should limit placebo controlled trials in cancer
23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of ...
Posted by Michael Wonder on 23 Aug 2018
U.S. FDA accepts for priority review BMS’ application for Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone in patients with relapsed or refractory multiple myeloma
23 August 2018 - Application based on results from Phase 2 ELOQUENT-3 study. ...
Posted by Michael Wonder on 23 Aug 2018
Y-mAbs receives breakthrough therapy designation for naxitamab for the treatment of high risk neuroblastoma
21 August 2018 - Y-mAbs Therapeutics today announced that the company has received a breakthrough therapy designation for naxitamab, in combination ...
Posted by Michael Wonder on 21 Aug 2018
FDA approves expanded label for Merck’s Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations
20 August 2018 - Approval based on results of KEYNOTE-189, where Keytruda in combination with pemetrexed and platinum chemotherapy reduced the ...