New Approvals, New Hope

OncLive Chairman,

Mike Hennessy

We are just completing the first quarter of 2015, and already there has been a series of exciting new treatment approvals offering new hope to patients with cancer.

The promise of PD-1 inhibition has officially reached patients with lung cancer with the approval of nivolumab (Opdivo) for the treatment of patients with advanced squamous non—small cell lung cancer who have progressed on or after platinum-based chemotherapy. The approval was announced 3 months ahead of the FDA’s scheduled decision date.

The FDA also recently approved the first US-authorized biosimilar, Zarxio (filgrastim-sndz), for all five authorized indications of its counterpart, the G-CSF analog Neupogen (filgrastim). Zarxio was the first product to be submitted and reviewed under the Biosimilar Pathway established by the federal government in 2010. The rationale behind the law is that expediting the approval of biosimilars will expand access and reduce costs. Let’s hope that promise is fulfilled as more of these products are added to the oncology armamentarium.

Other treatments approved in the recent flurry of FDA activity include lenvatinib (Lenvima) as a treatment for patients with progressive, radioactive iodine-refractory differentiated thyroid cancer, and lenalidomide (Revlimid) plus dexamethasone for newly diagnosed patients with multiple myeloma.

Beyond these new treatment options, this issue also includes highlights of emerging therapies discussed at the 2015 Genitourinary Cancer Symposium. Specifically, the anti—PD-L1 agent MPDL3280A, in combination with bevacizumab (Avastin), had strong antitumor activity and induced responses in 4 of 10 patients with metastatic renal cell carcinoma in an open-label phase Ib study (click here, to view more). Additionally, combining the investigational vaccine PROSTVAC with the immune checkpoint inhibitor ipilimumab (Yervoy) may improve overall survival in metastatic castration-resistant prostate cancer, according to findings from a phase I study (click here, to view more).

It’s been a great year in oncology so far. Let’s keep the momentum going! As always, thank you for reading.