HEADLINE Statement from Tim Turnham, Executive Director, Melanoma Research Foundation:Today the FDA approved Keytruda (pembrolizumab), a new treatment for advanced melanoma, the deadliest form of skin cancer. Melanoma patients have been waiting anxiously for this day, given the promising data that early studies have shown.
Regulatory
FDA Grants Merck’s Anti-PD1 Antibody Priority Review
The FDA has granted Merck’s anti-PD1 antibody MK-3475 a priority review designation for the treatment of unresectable or metastatic melanoma in patients who have previously been treated with ipilimumab. Priority review status is reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious condition. It will shorten the drug’s FDA review period from 10 months to 6 months.
Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma
Priority Review Designation for MK-3475 BLA for Proposed Indication of Unresectable or Metastatic Melanoma in Patients Who Have Been Previously Treated with IpilimumabAdvancing New Phase 3 Studies with MK-3475 in Adjuvant Melanoma, Previously-Untreated Non-Small Cell Lung Cancer, Advanced Head & Neck and Bladder CancersData from Studies in Three Different Cancer Types to be presented at 2014 ASCO Annual MeetingInitiating Phase 1 Study with Investigational Anti-GITR Antibody (MK-4166)
Galectin Therapeutics Receives FDA approval to proceed with Phase IB clinical trial in metastatic melanoma
Galectin Therapeutics has announced that the US Food and Drug Administration (FDA) has agreed that a Phase IB clinical trial of the galectin inhibitor GR-MD-02 in combination with Yervoy (ipilimumab) in patients with metastatic melanoma may proceed.