In the News

Vizimpro a New First-Line Targeted Therapy for Metastatic NSCLC with EGFR Mutations

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On September 27, 2018, the FDA approved the targeted therapy dacomitinib (Vizimpro; Pfizer), an oral kinase inhibitor, for the first-line treatment of patients with meta­static non–small-cell lung cancer (NSCLC) associated with EGFR exon 19 deletion or exon 21 L858R substitution mutations, as identified by an FDA-approved test. The FDA approved dacomitinib using its priority review process and granted it an orphan drug designation. [ Read More ]

Lumoxiti a New Treatment Approved for Patients with Hairy-Cell Leukemia

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On September 13, 2018, the FDA approved moxetumomab pasudotox-­tdfk (Lumoxiti; AstraZeneca), an intravenous CD22-directed cytotoxin, for adults with relapsed or refractory hairy-cell leukemia (HCL) who received ≥2 systemic therapies, including treatment with a purine nucleoside analog. The FDA used its fast track and priority review for this approval, and it granted moxetumomab pasudotox-tdfk an orphan drug designation for this indication. [ Read More ]

Sunitinib After Nephrectomy Benefits Some Patients with Advanced Kidney Cancer

October 2018, Vol 9, No 3 - In the Literature

Nephrectomy has been the standard of care in metastatic renal-cell carcinoma for 20 years. However, its role in treating patients with advanced disease in the era of targeted therapy has been brought into question. In the CARMENA study, researchers assessed the benefit of initial nephrectomy followed by targeted therapy with sunitinib (Sutent) in patients with metastatic kidney cancer versus the benefits provided by su­nitinib monotherapy. [ Read More ]

Talazoparib, a New PARP Inhibitor, Shows Significant Benefit in Patients with Breast Cancer and BRCA Mutation

October 2018, Vol 9, No 3 - In the Literature

Talazoparib, an oral investigational poly (ADP-ribose) polymerase (PARP) inhibitor, is currently being evaluated in advanced breast cancer with BRCA mutation and other cancer types. Talaz­oparib’s dual mechanism of action has the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage. [ Read More ]