FDA Places Hold on Cervical Cancer Trial Evaluating AIM2CERV
January 25th 2019A partial clinical hold has been placed on the phase III AIM2CERV trial by the FDA, Advaxis, Inc. has announced.<sup>1</sup> The trial is evaluating the use of the investigational immunotherapy agent axalimogene filolisbac in high-risk locally advanced cervical cancer.
Safety, Efficacy of Atezolizumab Being Investigated in Phase III SCCHN Trial
January 8th 2019An ongoing randomized phase III clinical trial is investigating the safety and efficacy of atezolizumab compared with placebo as an adjuvant treatment after definitive local therapy in patients with high-risk, locally advanced squamous cell carcinoma of the head and neck.
Novel Agent Shows Benefit Combined with Nivolumab in Microsatellite Stable CRC
December 20th 2018Novel immunomodulatory agent pixatimod combined with nivolumab, a PD-1 inhibitor, may benefit patients with advanced bowel cancers, including a small subset of those with colorectal cancer considered to be microsatellite stable.
Cemiplimab Combo Does Not Show Superior ORR to Anti-PD-1 Monotherapy in Advanced HNSCC
December 13th 2018The PD-1 inhibitor cemiplimab in combination with radiotherapy, cyclophosphamide, and granulocyte-macrophage colony-stimulating factor did not demonstrate efficacy superior to other PD-1 inhibitor monotherapies in patients with recurrent or metastatic head and neck squamous cell carcinoma, according to results from a phase I expansion cohort that were presented at the 2018 ESMO Congress.
Supplemental Application for Avatrombopag in ITP Accepted by FDA
November 9th 2018A supplemental new drug application (sNDA) for avatrombopag (Doptelet) as a treatment for patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to prior treatment has been accepted for review by the FDA.