Novocure bags mesothelioma nod for electric fields cancer therapy with some limitations
Novocure has secured the FDA’s blessing for another use of its tumor treating fields: malignant pleural mesothelioma, a rare cancer that develops in the linings of the lung and chest.
The NovoTTF-100L System is to be deployed with Eli Lilly’s Alimta (pemetrexed) and a platinum-based chemotherapy in the first-line treatment of unresectable, locally advanced or metastatic forms of the disease. Currently, only 10% to 20% of MPM patients are candidates for surgery to remove the tumor, according to Mary Hesdorffer of the Mesothelioma Applied Research Foundation.
It marks the second approved use for the electric fields system pioneered by founder Yoram Palti, professor emeritus of physiology and biophysics at the Israel Institute of Technology since Novocure began treating glioblastoma patient with the tech in 2011. That therapy, Optune, is subject of a partnership deal with China’s Zai Lab.
Notably, though, for the new OK, regulators went through the humanitarian device exemption pathway, which carries no requirement for evidence of effectiveness.
Novocure, though, is eager to showcase how their treatment — which features electric fields tuned to specific frequencies to disrupt solid tumor cell division — can extend survivals in some of the more aggressive forms of cancer.
In a single-arm trial with 80 patients, NovoTTF-100L plus chemo achieved a median overall survival of 18.2 months without increasing serious adverse events, compared to 12.1 months in the historical control.
“FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure,” Bill Doyle, Novocure’s executive chairman.
While limited in the quantity it can distribute due to its humanitarian device status, the new commercialization drive will likely also go some way in solidifying its financial operation after it obtained a $150 million term loan from BioPharma Credit last February, mostly to repay an existing debt but also to fund working capital.
Image: Kristoffer Tripplaar for Sipa USA. AP