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RSS FeedPosted by Michael Wonder on 05 Oct 2019
FDA grants breakthrough therapy designation to cobimetinib for MEK inhibition in histiocytic neoplasms, research led by MSK
2 October 2019 - Memorial Sloan Kettering Cancer Center announced today that the US FDA has granted a breakthrough therapy designation ...
Posted by Michael Wonder on 04 Oct 2019
Janssen announces U.S. FDA breakthrough therapy designation granted for niraparib for the treatment of metastatic castration-resistant prostate cancer
3 October 2019 - Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant ...
Posted by Michael Wonder on 03 Oct 2019
FDA approves labeling supplement for Puma Biotechnology’s Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer
2 October 2019 - Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide ...
Posted by Michael Wonder on 01 Oct 2019
US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017
1 October 2019 - With the advent of patient-focused drug development, the US FDA has redoubled its efforts to review patient-reported ...
Posted by Michael Wonder on 26 Sep 2019
FDA approves daratumumab for transplant eligible multiple myeloma
26 September 2019 - The FDA has today approved daratumumab (Darzalex, Janssen) for adult patients with multiple myeloma in combination ...
Posted by Michael Wonder on 23 Sep 2019
Xynomic Pharma receives fast track designation from the US FDA for abexinostat as fourth-line therapy treating follicular lymphoma
23 September 2019 - Xynomic Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to Xynomic’s lead ...
Posted by Michael Wonder on 18 Sep 2019
Susan G. Komen Big Data for Breast Cancer Initiative: how patient advocacy organisations can facilitate using big data to improve patient outcomes
12 September 2019 - Integrating different types of data, including electronic health records, imaging data, administrative and claims databases, large data ...
Posted by Michael Wonder on 18 Sep 2019
U.S. FDA approves supplemental new drug application for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer
17 September 2019 - Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of ...
Posted by Michael Wonder on 17 Sep 2019
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
17 September 2019 - The U.S. FDA is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 16 Sep 2019
Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer
16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020. ...
Posted by Michael Wonder on 11 Sep 2019
Puma Biotechnology announces U.S. FDA acceptance of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer
11 September 2019 - Puma Biotechnology announced that the U.S. FDA has accepted for review its supplemental new drug application for ...
Posted by Michael Wonder on 11 Sep 2019
Merck announces FDA breakthrough therapy designation for investigational therapy tepotinib in patients with metastatic NSCLC with METex14 skipping alterations
11 September 2019 - Investigational oral MET inhibitor has previously received SAKIGAKE ’fast-track’ regulatory designation in Japan. ...
Posted by Michael Wonder on 09 Sep 2019
Who’s missing from breast cancer trials? Men, says the FDA
9 September 2019 - Men do get breast cancer, but they account for fewer than 1 percent of patients and often ...
Posted by Michael Wonder on 09 Sep 2019
FDA grants AMG 510 fast track designation for previously treated metastatic NSCLC with KRAS G12C mutation
8 September 2019 - Amgen today announced new data from the ongoing Phase 1 study evaluating AMG 510 in patients with ...
Posted by Michael Wonder on 06 Sep 2019
Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA breakthrough therapy designation for patients with MET-mutated advanced non-small cell lung cancer
6 September 2019 - Regulatory filing for capmatinib in the U.S. is anticipated in Q4 2019. ...