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Jason M. Broderick

Articles by Jason M. Broderick

The FDA has expanded the label of ibrutinib (Imbruvica) to include overall survival results in treatment-naive patients with chronic lymphocytic leukemia, as well as outcomes with the BTK inhibitor when combined with bendamustine and rituximab in relapsed/refractory patients with CLL.

Everolimus (Afinitor) has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use as a treatment for patients with progressive, unresectable or metastatic, well-differentiated nonfunctional gastrointestinal or lung neuroendocrine tumors.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-1 against the accelerated approval of rociletinib as a treatment for patients with metastatic EGFR T790M–mutated non–small cell lung cancer (NSCLC) who have previously received an EGFR-targeted therapy.

The FDA approved the BCL-2 inhibitor venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion (del[17p]), following at least 1 prior therapy.

The FDA has granted a priority review to atezolizumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.

The FDA has approved Captisol-enabled melphalan (Evomela) as a high-dose conditioning treatment for use in patients with multiple myeloma prior to autologous stem cell transplantation, as well as for the palliative treatment of patients with myeloma for whom oral therapy is not appropriate.