mercurius-adept schreef op 29 november 2023 20:58:
Leerink analyst:
Currently, secondary malignancies are listed in the “warnings and precautions” section of every CAR-T therapy’s label. Should the FDA take regulatory action, the Leerink team argued the agency would most likely:
1.
flag the risk in a black-box warning, which is the highest level of a safety alert on a medication’s label. That wouldn’t be too big a problem, given CAR-Ts already have several boxed warnings, including for potentially life-threatening cytokine release syndrome and neuro toxicities.
2. Alternatively, the FDA could decide to
restrict CAR-T use to high-risk patients or to later-line treatment settings, the Leerink analysts said. Such actions would limit these products’ commercial potential in a meaningful way.
3. “A worst-case scenario is that today’s FDA announcement portends
increased scrutiny and higher risk/benefit bar for CAR-T in earlier lines and settings beyond oncology,” the Leerink analysts wrote in their note Tuesday
www.fiercepharma.com/pharma/fda-inspe...