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Policy Prescriptions: Kite's CAR-T; Price And Value Scrutiny; Biosimilars; Manufacturing Missteps

 
• By Denise Peterson

Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.

Policy Prescriptions

Kite Pharma Inc.anticipates a smooth path to US approval of its CAR-T therapy axicabtagene ciloleucel for patients with aggressive non-Hodgkin lymphoma who are not candidates for autologous stem cell transplants. The company won't need an FDA advisory panel review and reported progress on other activities related to its BLA, including manufacturing inspections. (Also see "Kite’s Axi-Cel CAR-T: No Adcomm, No Problem" - Pink Sheet, 11 August, 2017.) That disclosure comes about a month after the FDA Oncologic Drugs Advisory Committee's unanimous thumbs up for approval ofNovartis AG's CTL019 (tisagenlecleucel), an action widely hailed as a milestone for the CAR-T field as stakeholders look forward to a first approval. (Also see "Novartis' CAR-T Poised For The Market After Unanimous FDA Adcomm Review" - Scrip, 13 July, 2017.) Kite said it should have launch procedures ready to go by mid-September – its user fee review date is Nov. 29 – having met with insurers and training key staff teams. While sponsors often benefit from an adcomm's public vetting of cutting-edge therapy, Kite seems to moving be full speed ahead now.

The Novartis and Kite products will serve as case-studies for ICER's planned review of CAR-T (chimeric antigen receptor T-cell) therapies....

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