Hogan Lovells advises Novocure on historic FDA approval for Optune Pax® Pancreatic Cancer Treatment
Washington, D.C. – Global law firm Hogan Lovells advised Novocure in connection with its recent U.S. Food and Drug Administration approval for Optune Pax® for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. Optune Pax concomitant with gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.
FDA also announced the approval, referring to Optune Pax as a “first-of-its-kind device.” The announcement included comments from the FDA commissioner and the Center for Devices and Radiological Health director celebrating the advancement and additional therapeutic option now available to patients.
Optune Pax is a portable therapeutic device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that target the electrical properties of cancer cells to disrupt processes critical for cancer cell division and survival, resulting in cell death without significantly affecting healthy cells. In the device’s Phase 3 PANOVA-3 trial, results showed a statistically significant improvement in overall survival (OS) in patients treated with Optune Pax compared to gemcitabine and nab-paclitaxel alone.
The Hogan Lovells team that advised on this approval included partner Kristin Zielinski Duggan, senior counsel Jonathan Kahan, senior counsel emeritus Gerard J. Prud’homme, and senior associate Megana Sankaran.
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