Novel Mesothelioma Treatment Closer to FDA Approval

Standard-of-care treatment for patients with pleural mesothelioma may soon include Tumor Treating Fields (TTF), a novel therapy involving electric currents that disrupt cancer cell division and inhibit tumor growth. In the wake of recently released results from Novocure’s STELLAR phase II clinical trial, the U.S. Food and Drug Administration (FDA) is expected to approve the treatment within the next six months, giving mesothelioma patients another much-needed option. “At this point, it should be a relatively rapid approval process,” Dr. Eilon Kirson, chief science officer at Novocure, the oncology company designing the therapy, told Asbestos.com. “We’ve been working with the FDA to make it happen. The data is approvable, from a clinical trial design point of view, a statistical point of view, and from a clinical benefit point of view.” The FDA has not approved a new treatment option for pleural mesothelioma since 2004 when the chemotherapy drug Alimta (pemetrexed) was added. A 50 Percent Improvement In the STELLAR clinical trial, TTF was combined with standard chemotherapy — Alimta and either cisplatin or carboplatin — and compared to a historical control model of standard chemotherapy alone. The results include an 18.2-month median overall survival for the TTF group, a significant improvement over the 12.1 months for those receiving only chemotherapy. There was no reported increase in systemic toxicity. “It’s not the cure we’re all looking for, but it m...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Source Type: news