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RSS FeedPosted by Michael Wonder on 02 Jun 2020
Y-mAbs announces U.S. FDA acceptance of biologics license application for Danyelza (naxitamab) for the treatment of neuroblastoma for priority review
2 June 2020 - Y-mAbs Therapeutics today announced that the biologics license application for Danyelza (naxitamab) for the treatment of patients ...
Posted by Michael Wonder on 02 Jun 2020
CDK 4/6 inhibitor market to heat up on insurance benefits
2 June 2020 - Despite such high unmet medical needs, the drug has long been out of reach for patients ...
Posted by Michael Wonder on 02 Jun 2020
Ribociclib succinate in breast cancer: added benefit for certain post-menopausal women
2 June 2020 - Re-valuations after the expiry of the time limit new data cuts confirm advantages and disadvantages ...
Posted by Michael Wonder on 02 Jun 2020
European Commission approves Sarclisa (isatuximab) for adults with relapsed and refractory multiple myeloma
2 June 2020 - EC approval based on data from first randomised Phase 3 trial (ICARIA-MM) to report results evaluating an ...
Posted 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 02 Jun 2020
Lynparza recommended for approval in EU by CHMP for BRCA mutated metastatic pancreatic cancer
1 June 2020 - Only PARP inhibitor to demonstrate patient benefit in a Phase III trial in this setting. ...
Posted by Michael Wonder on 01 Jun 2020
New combination therapy now reimbursed for Australians living with incurable blood cancer
1 June 2020 - New combination therapy now reimbursed for Australians living with incurable blood cancer. ...
Posted by Michael Wonder on 31 May 2020
CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer
29 May 2020 - Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, ...
Posted by Michael Wonder on 31 May 2020
Novartis Piqray receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation
29 May 2020 - Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast ...
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
NICE issues final guidance on NHS use of Bayer's Vitrakvi
27 May 2020 - The NICE has published final guidance recommending NHS use of Bayer's Vitrakvi (larotrectinib) for a variety ...
Posted by Michael Wonder on 27 May 2020
NICE recommends treatment for type of small-cell lung cancer
27 May 2020 - A new treatment option for patients with extensive-stage small-cell lung cancer has been approved by NICE. ...
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. ...