publication date: Jul. 11, 2014
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FDA Grants Breakthrough Therapy Designation to CTL019 in ALL
FDA granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia.
The filing was submitted by the University of Pennsylvania’s Perelman School of Medicine, which has an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR T cell therapies for the treatment of cancers.
According to the FDA, the designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint. The designation includes all of the fast track program features, as well as more intensive FDA guidance.
It is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.
The European Commission issued marketing authorization approval for Halaven (eribulin) for locally advanced or metastatic breast cancer that has progressed after at least one chemotherapeutic regimen for advanced disease.
Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
The authorization for eribulin is based on clinical evidence from two global Phase III trials; EMBRACE and study 301. These studies involved more than 1,800 women.
EMBRACE showed eribulin can prolong median overall survival in heavily pre-treated women with MBC compared to women receiving an alternative treatment of physician’s choice by … Continue reading 40-28 FDA Grants Breakthrough Designation to CTL019 in ALL
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