ASCO In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Celgene Revlimid MDS data: Celgene's immunomodulatory drug Revlimid (lenalidomide) achieved a 70% cytogenetic response rate in a pivotal, Phase II trial (MDS-003) including 148 patients with 5q deletion myelodysplastic syndromes, the company reports May 15 at the American Society of Clinical Oncology meeting in Orlando, Fla. The firm notes that 66% of the 146 patients who were transfusion dependent at baseline achieved transfusion independence and a median hemoglobin increase of 5.3 g/dL. Investigators concluded that lenalidomide has "unprecedented hematologic and [cytogenetic] remitting activity." Celgene completed a rolling submission of its Revlimid NDA for MDS patients with the 5q abnormality in March; a priority review is expected...
You may also be interested in...
Erbitux head/neck cancer sBLA delay
Bristol-Myers Squibb and ImClone will delay submission of Erbitux (cetuximab) for head and neck cancer until the end of the year to allow for an independent review of a pivotal Phase III study (IMC-9815). The companies originally planned a second-quarter submission. The delay is needed "to conduct additional and independent analysis of the primary endpoint of...locoregional control," ImClone Chief Medical Officer Eric Rowinsky explained during an April 13 conference call. The trial's secondary endpoint of survival will not be subject to independent review, according to the company...
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: