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RSS FeedPosted by Michael Wonder on 24 Feb 2017
Tocagen receives breakthrough therapy designation from U.S. FDA for Toca 511 & Toca FC in recurrent high grade glioma
23 February 2017 - Tocagen today announced the U.S. FDA has granted Toca 511 & Toca FC breakthrough therapy designation for ...
Posted by Michael Wonder on 23 Feb 2017
Novartis drug Zykadia receives FDA priority review for first-line use in patients with ALK+ metastatic NSCLC
23 February 2017 - Priority review based on Phase III study results showing 16.6 month median progression-free survival in previously untreated ...
Posted by Michael Wonder on 23 Feb 2017
FDA expands indication for Revlimid (lenalidomide) as a maintenance treatment for patients with multiple myeloma following autologous haematopoietic stem cell transplant (auto-HSCT)
22 February 2017 - Approval enables Celgene to provide patients with treatment options across the multiple myeloma spectrum. ...
Posted by Michael Wonder on 22 Feb 2017
FDA’s Pazdur and Blumenthal: the march of checkpoint inhibitors will continue
21 February 2017 - More approvals of new immune-checkpoint inhibitors, targeted and personalised therapies, as well as the use of ...
Posted by Michael Wonder on 15 Feb 2017
Amgen submits supplemental biologics license application for Blincyto (blinatumomab) in relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
14 February 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to ...
Posted by Michael Wonder on 15 Feb 2017
Quality of life, overall survival and costs of cancer drugs approved based on surrogate outcomes
14 February 2017 - The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US ...
Posted by Michael Wonder on 14 Feb 2017
American patients can access far more new cancer drugs than others can
13 February 2017 - New research by scholars at the University of Pittsburgh shows that American patients have significantly better access ...
Posted by Michael Wonder on 09 Feb 2017
Amid flurry of new cancer drugs, how many offer real benefits?
9 February 2017 - Marlene McCarthy's breast cancer has grown relentlessly over the past seven years, spreading painfully through her ...
Posted by Michael Wonder on 03 Feb 2017
FDA accepts two sBLAs for Merck’s Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings
3 February 2017 - Keytruda also receives breakthrough therapy designation for second-line treatment based on KEYNOTE-045, which includes primary endpoints ...
Posted by Michael Wonder on 03 Feb 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
2 February 2017 - Approval based on CheckMate-275, in which Opdivo demonstrated an objective response rate of 19.6% (95% CI: 15.1-24.9; ...
Posted by Michael Wonder on 23 Jan 2017
Bristol-Myers Squibb provides regulatory update in first-line lung cancer
19 January 2017 - All first-line lung registrational studies continue. ...
Posted by Michael Wonder on 19 Jan 2017
Statement from FDA Commissioner announcing FDA Oncology Center of Excellence launch
19 January 2017 - Today the U.S. FDA is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard ...
Posted by Michael Wonder on 19 Jan 2017
U.S. FDA approves Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma - a rare type of non-Hodgkin's lymphoma
19 January 2017 - Imbruvica will be a chemotherapy-free option for patients with marginal zone lymphoma who failed prior therapies. ...
Posted by Michael Wonder on 11 Jan 2017
Merck receives FDA acceptance of supplemental biologics license application for Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer
10 January 2017 - Submission based on data from KEYNOTE-021 trial, cohort G, which enrolled patients regardless of PD-L1 expression. ...
Posted by Michael Wonder on 09 Jan 2017
FDA grants Roche’s cancer immunotherapy Tecentriq (atezolizumab) priority review in additional type of advanced bladder cancer
9 January 2017 - Second priority review granted for Tecentriq in advanced bladder cancer. ...