Selinexor Approved for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
On June 22, 2020, the FDA granted accelerated approval to the nuclear export inhibitor selinexor (Xpovio) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. The approval is based on the results of the multicenter, single-arm phase IIb SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study, which assessed 134 patients with relapsed or refractory DLBCL. Read more. |
FDA Approves Another Indication for Pembrolizumab
On June 24, 2020, the manufacturer of pembrolizumab (Keytruda) announced that the FDA approved this agent for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation. This approval is based on data from the phase II KEYNOTE-629 trial, in which pembrolizumab demonstrated meaningful efficacy and durability of response, with an objective response rate of 34%, including a complete response rate of 4% and a partial response rate of 31%. Read more. |