All News

FDA Approves Crizotinib in Pediatric ALK+ Relapsed or Refractory Systemic ALCL

January 14, 2021

The FDA granted approval to the antineoplastic tyrosine kinase inhibitor, crizotinib, as treatment of pediatric patients 1 year of age and older and young adults with ALK alteration-positive relapsed or refractory systemic anaplastic large cell lymphoma.

Zotiraciclib Plus Temozolomide Shows Early PFS Benefit in Recurrent Gliomas

January 14, 2021

The investigational, potent, oral CDK9 inhibitor, zotiraciclib in combination with temozolomide, demonstrated early improvement in progression-free survival as treatment of patients with recurrent high-grade gliomas, meeting the primary end point of the phase 1B 17-C-0009 trial clinical trial.

Tissue TMB Shows Potential as Biomarker of Response to Pembrolizumab in Thyroid Cancer

January 12, 2021

Patients with tissue tumor mutational burden-high solid tumors represent a subset of patients who could have a robust tumor response to the immune checkpoint inhibitor pembrolizumab as monotherapy, suggesting tTMB may be a novel and useful predictor of response in patients with previously treated recurrent or metastatic advanced solid tumors, including thyroid cancer.

Ibrutinib-Based 1L Therapy Sustains Efficacy, Safety in TP53+ Chronic Lymphocytic Leukemia

January 12, 2021

The sustainability of efficacy and safety with frontline ibrutinib-based therapy used to treat patients with chronic lymphocytic leukemia who have TP53 aberrations was demonstrated, according to 4-year follow-up result of a pooled analysis.

FDA Grants Fast Track Designations in Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma

January 12, 2021

The FDA granted 2 Fast Track designations to the cavrotolimod for 2, including in combination with anti-PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma who are refractory to prior anti-PD-1 blockade and in combination with anti-PD-1/PD-L1 in patients with locally advanced or metastatic cutaneous squamous cell carcinoma who are refractory to prior anti-PD-1/PD-L1 blockade.

Exploring the Rationale for OP-1250 in Advanced HR-Positive HER2-Negative Breast Cancer

January 12, 2021

Erika P. Hamilton, MD, discusses the rationale for exploring OP-1250 monotherapy in an open-label first-in-human multi center phase 1/2 study in adult patients with advanced and/or metastatic hormone receptor-positive, HER2-negative breast cancer.