All Oncology News

The FDA has granted a regular approval to osimertinib as a treatment for patients with metastatic EGFR T790M mutation-positive non–small cell lung cancer following prior treatment with an EGFR TKI, based on progression-free survival findings from the phase III AURA3 trial.

The FDA has granted a priority review designation to tisagenlecleucel-T as a treamtnet for pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia, making it the first CAR T-cell therapy to enter regulatory review.

The FDA has approved the PARP inhibitor niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

The EMA’s Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have progressed following autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.

Male breast cancer is a rare and poorly understood disease, but recent molecular studies have revealed fundamental differences from female breast cancer that could help guide treatment strategies toward a more tailored approach.