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FDA advisory committee closes door to single-arm trial of PI3K inhibitors
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FDA advisory committee closes door to single-arm trial of PI3K inhibitors.
April 21, 2022, 16 in favor, 0 against, 1 abstention – FDA Oncology Drugs Advisory Committee (ODAC) Support: Future approval of PI3K inhibitors should be based on randomized data rather than single-arm trials.
So far, the FDA has approved 4 PI3K inhibitors for the treatment of hematological malignancies based on single-arm data, namely: idelalisib (Zydelig), copanlisib (Aliqopa), duvelisib (Copiktra), umbralisib (Ukoniq), Ukoniq has recently Withdrawal from the market (note: failed to show OS benefit based on UNITY-CLL trial results).
All 4 drugs showed improvement in ORR or PFS. However, the results of 6 post-marketing randomized controlled trials have shown that OS may be compromised, and serious and fatal adverse reactions may occur.
One of the committee members, Dr. Christopher Lieu, from the University of Colorado Cancer Center, said: “Achieving an OS endpoint for an indolent cancer is costly and time-consuming, and if there are likely to be significant adverse effects at the time of treatment, PFS is a regulatory-approved endpoint. End point, it may not be reasonable.”
“Companies have an obligation to demonstrate that their products are safe and effective,” the FDA said at the hearing. “These products are not adequately supported based on estimated OS, prior data information, observed toxicity profiles, and questionable dose selection. is a safe conclusion.”
Dr. Lieu concluded: “Based on the data available, we would like to see a trend in OS benefit. Bottom line: if we don’t extend patients’ lives with any treatment, we expose them to toxicity and reduce their quality of life. , are we really helping patients? I don’t believe it.”
(source:internet, reference only)