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    Cancer immunotherapy alternative dosing regimens: New FDA draft guidance

    New draft guidance for developers of cancer immunotherapies will help them support alternative dosing regimens with pharmacokinetic-based criteria.   The newly available draft guidance from the US Food and Drug Administration (FDA), wrote the agency in the draft, can be used when sponsors “seek approval of alternative intravenous (IV) dosing regimens that are different from those tested in clinical efficacy and safety trials.”   Programmed cell death receptor-1 (PD...
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    ODAC recommends pulling 2 of 6 accelerated approvals

    “Dangling” accelerated approvals of cancer immunotherapies were on the docket for a 3-day session of the US Food and Drug Administration’s oncology advisory committee that wrapped up on 29 April. After 2 days of relatively smooth sailing for the first half of the six indications on the docket, the final day saw two recommendations for withdrawal – and unexpected fireworks from FDA staff.   Of six indications put before ODAC, just two were recommended for withdrawal, de...
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    FDA adcomm declines to yank accelerated approvals for cancer immunotherapies

    At the halfway mark in its review of six “dangling” accelerated approvals for cancer immunotherapies, an advisory committee to the US Food and Drug Administration has declined to rescind approvals for any of the indications it has reviewed to date, citing immature data and ongoing unmet patient need.   FDA’s Oncologic Drugs Advisory Committee (ODAC), convening virtually, has thus far reviewed two indications for Genentech’s Tecentriq (azetolizumab) and one for Merck, S...
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    Cancer Immunotherapies: EMA to Hold November Workshop

    The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria). As EMA explains, “Immunotherapy is a type of cancer treatment that mobilizes the body's own defense mechanisms to fight cancer. Immunotherapy m...
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    European Regulatory Roundup: UK Lord Tries to Reassure Politicians on Brexit Life Science Strategy (11 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Lord Tries to Reassure Politicians About Brexit Life Science Strategy A member of the United Kingdom’s House of Lords has tried to reassure politicians who questioned the effect of Brexit on life sciences that the government has the situation under control. David Prior, the parliamentary under secretary of state for health in the Lords, made the comments in a lette...