Novocure touts preliminary data on tumor treating fields.

NovoCure (NSDQ:NVCR) said yesterday that a retrospective analysis of its Tumor Treating Fields therapy showed it safe in adult glioblastoma patients with implanted non-programmable shunts.

The FDA removed a pre-existing contraindication in October based on the safety data that contraindicated the therapy for patients with non-programmable shunts, Novocure said.

The data was presented last month at the Society for Neuro-Oncology’s annual meeting in San Antonio, Texas.

“The removal of the contraindication from its regulatory labeling increases Optune’s addressable GBM patient population by approximately 5%. Novocure strives to ensure the safety and efficacy of TTFields in all patients. This research supports that mission, while making our therapy available to a growing number of patients who suffer from this aggressive form of brain cancer,” CEO Asaf Danziger said in a press release.

The data came from the analysis of 1,402 recurrent glioblastoma patients treated with TTFields therapy over the last 4 years. Of the patietns, 49 had implanted devices, 44 had non-programmable shunts, 2 had programmable shunts and 3 had pacemakers or defibrillators

Novocure said that adverse events reported from the 49 patients with implanted medical devices didn’t reveal any new data, and the analysis indicated that TTFields therapy is safe for patients with non-programmable shunts.

The St. Helier, N.J.-based company said it would need further investigation to determine whether the therapy is safe for patients with programmable shunts.

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