CLEVELAND, Ohio — Dr. Roger Macklis sees radiation oncology as a revolutionary treatment shunned by some like it’s a rogue science.
From that perspective, it was a good day for medical rebels. Spectrum Pharmaceuticals said on Friday that the U.S. Food and Drug Administration expanded the label for Zevalin, allowing that radioimmunotherapy to be used as part of a first-line treatment for certain non-Hodgkins lymphoma. Spectrum owns Zevalin.
“I consider this to be a classic disruptive technology that’s a disadvantage to the status quo,” Macklis said. “There’s been a lot of pushback against these technologies.”
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Macklis, a radiation oncologist at Cleveland Clinic, has for years agitated for an expanded role for radioimmunotherapy — not just Zevalin, but also for its competitor Bexxar. He’s campaigned for the last seven years for a change similar to what the FDA granted Zevalin. He has spent time uniting his peers through online social networks, lobbying drugs companies, researching and speaking publicly about the issue.
He is a paid speaker for Spectrum Pharmaceuticals, which purchased Zevalin this year, and is a member of its scientific advisory board.
The FDA’s label change will open the drug up to another 43,000 patients. The federal government approved the change through the research in a study that showed patients with follicular non-Hodgkin’s Lymphoma went more than twice as long without a recurrence of the cancer when treated with Zevalin.
“I view this as a validation of the field of radioimmunotherapy, but in my mind this is only a piece of the pie,” Macklis said. Macklis wants the same kind of FDA approval for Zevalin’s competitor, Bexxar, and for researchers to consider the possibility that these kinds of treatments may even be better than chemotherapy itself.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
“This is moving forward, but the whole ball is not over the goal line,” he said.
