Blog
RSS FeedPosted by Michael Wonder on 02 Jun 2020
AVEO Oncology announces FDA acceptance for filing of a new drug application for tivozanib as a treatment of relapsed or refractory renal cell carcinoma
1 June 2020 - Tivozanib assigned PDUFA target action date of 31 March 2021; FDA indicates that it does not currently ...
Posted by Michael Wonder on 31 May 2020
FDA approves Genentech’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
29 May 2020 - Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 31 May 2020
Lilly's Cyramza (ramucirumab) receives FDA approval as first-line treatment for metastatic EGFR mutated non-small cell lung cancer
29 May 2020 - Cyramza, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell ...
Posted by Michael Wonder on 28 May 2020
Cardiff Oncology announces fast track designation granted by the FDA to onvansertib for second-line treatment of KRAS mutated colorectal cancer
28 May 2020 - Fast Track designation for onvansertib in KRAS mutated metastatic colorectal cancer underscores the urgent need for new ...
Posted by Michael Wonder on 27 May 2020
U.S. FDA approves Opdivo (nivolumab) and Yervoy (ipilimumab) combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer
26 May 2020 - Approval marks sixth indication for Opdivo and Yervoy-based combinations across five types of cancer. ...
Posted by Michael Wonder on 27 May 2020
Cellectar receives FDA fast track designation for CLR 131 in lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinaemia
26 May 2020 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in lymphoplasmacytic ...
Posted by Michael Wonder on 23 May 2020
U.S. FDA approves Takeda’s Alunbrig (brigatinib) as a first-line treatment option for patients diagnosed with rare and serious form of lung cance
22 May 2020 - Long-term results from the Phase 3 ALTA 1L trial established Alunbrig as a superior first-line treatment compared ...
Posted by Michael Wonder on 20 May 2020
Karyopharm submits supplemental new drug application to FDA for Xpovio (selinexor) as a treatment for patients with multiple myeloma after at least one prior line of therapy
20 May 2020 - Karyopharm Therapeutics today announced it has submitted a supplemental new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 20 May 2020
Lynparza approved in the US for HRR gene-mutated metastatic castration-resistant prostate cancer
20 May 2020 - Only PARP inhibitor to improve overall survival versus enzalutamide or abiraterone in a biomarker-based subset of prostate ...
Posted by Michael Wonder on 18 May 2020
FDA approves Genentech’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer
18 May 2020 - Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall. ...
Posted by Michael Wonder on 18 May 2020
Blueprint pays the price of Ayvakit phase 3 miss as FDA rejects drug
18 May 2020 - The FDA has turned down Blueprint Medicines’ Ayvakit for more general use in gastro-intestinal stromal tumour ...
Posted by Michael Wonder on 18 May 2020
Enhertu granted breakthrough therapy designation in the U.S. for HER2 mutant metastatic non-small cell lung cancer
18 May 2020 - Designation based on phase 2 DESTINY-Lung01. ...
Posted by Michael Wonder on 17 May 2020
Blueprint Medicines receives complete response letter from FDA for avapritinib new drug application for the fourth-line treatment of gastro-intestinal stromal tumour
15 May 2020 - Blueprint Medicines today announced that the U.S. FDA has issued a complete response letter for the new ...
Posted by Michael Wonder on 15 May 2020
FDA approves first drug for fourth-line treatment of advanced gastro-intestinal stromal tumours
15 May 2020 - Today, the U.S. FDA approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a ...
Posted by Michael Wonder on 15 May 2020
FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer
15 May 2020 - Today the FDA granted accelerated approval to rucaparib (Rubraca, Clovis Oncology) for patients with deleterious BRCA ...