Arizonans will receive benefit from recently FDA-approved precision medicine clinical trial to fight deadly melanoma
Regulatory
ASCO 2015: Opdivo melanoma phase III beats Yervoy in combo and alone
Bristol-Myers Squibb Co.’s programmed cell death-1 inhibitor Opdivo (nivolumab), cleared by the FDA late last year for melanoma and in March for squamous non-small cell lung cancer (NSCLC), worked better than the firm’s other approved melanoma drug Yervoy (ipilimumab) in patients with previously untreated cases of the deadly skin cancer not only when the two drugs were given together but also when Opdivo was administered by itself.
As FDA Considers Approval, Weber Discusses Adjuvant Ipilimumab in Melanoma
In the EORTC 18071 study, patients with melanoma who received ipilimumab (Yervoy; n = 475) had an average recurrence-free survival of 26.1 months versus 17.1 months in placebo-treated patients (n = 476). Additionally, 46.5% of ipilimumab-treated patients survived 3 years without experiencing recurrence compared to 34.8% of patients in the control arm.
FDA Grants Orphan Drug Designation to Aura Biosciences’ Novel Treatment for Uveal Melanoma
CAMBRIDGE, Mass. Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has been granted Orphan Disease Designation by the FDA for its drug AU-011 for the treatment of Uveal Melanoma. The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics, which demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions in the US. In addition, the first oral presentation of Aura Biosciences’ pre-clinical research, ‘Evaluating the in vivo efficacy of a first-in-class drug for the treatment of primary uveal melanoma’, was recently delivered by McGill University Health Centre researchers at the ARVO (Association for Research in Vision and Ophthalmology) Annual Meeting.