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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Pazdur: Oncology accelerated approvals under review by ODAC

    On 27 April, the US Food and Drug Administration’s Oncology Drugs Advisory Committee (ODAC) meets to consider the fate of a half-dozen oncology immunotherapy indications granted accelerated approval. The confirmatory trials of these drugs have not verified their clinical benefit in the indications for which they received approval.   The virtual meeting will take stock of the indications individually; committee members will engage in a “general discussion focused on nex...
  • Regulatory NewsRegulatory News

    FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy

    The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy. Although the outside panel of experts raised questions about concerns with the safety and manufacturing of the Novartis treatment, known as CTL019 (tisagenlecleucel-T), the panel did not question the effi...
  • Regulatory NewsRegulatory News

    Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments

    Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive hefty sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week. “We found that most (92.1%) expert speakers at FDA ODAC meetings receive sizable industry payments (median, $35,435). We were unable to establish payments made from the specific ...
  • FDA: Send Us Your Pediatric Oncology Drugs

    • 07 August 2012
    The US Food and Drug Administration (FDA) is calling for the submission of pharmaceutical and biological products worthy of being brought before its Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) on 4 December 2012. ODAC is a 13-member committee charged with reviewing and evaluating data regarding the safety and effectiveness of cancer fighting drugs. Its pediatric subcommittee places an emphasis on oncology products intended for children-a produ...