In rejecting Spectrum Pharmaceuticals drug poziotinib, the FDA said the biotech needs to generate more data from another clinical trial. Instead, Spectrum is turning the company’s focus to commercializing its recently approved product for treating a common cancer complication.
Spectrum Pharmaceuticals and Oncopeptides each received separate negative advisory committee votes for their respective cancer drugs. In other recent regulatory news, clinical trial holds were placed and lifted and the FDA is seeking public comment on its draft guidance for including children in clinical trials.
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.
Spectrum said the FDA had accepted its application for Rolontis, which had shown non-inferiority to Amgen's Neulasta in Phase III testing. However, oncologists expressed mixed opinions about the drug.
Poziotinib did not show an improved response rate among previously treated non-small cell lung cancer patients with a specific genetic mutation, but additional cohorts in the Phase II study are ongoing.
CEO Joe Turgeon said in an interview that the company aims to focus more on developing drugs for larger, broader and more lucrative oncology markets.
The company plans a Phase II study next year in a subset of non-small cell lung cancer patients who usually don't respond to existing therapies.
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.
Dr. Roger 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.