ODAC votes unanimously in support of use of randomized data in PI3K inhibitor trials

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

FDA seeks consumer representatives for the Oncologic Drugs Advisory Committee

FDA is seeking consumer representatives to serve on the Oncologic Drugs Advisory Committee.

September 13, 2024

Vol.50 No.34

Clinical Trials & Tribulations

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

At its most recent meeting, the FDA Oncologic Drugs Advisory Committee focused on perioperative clinical trials, which the agency defined as neoadjuvant phase followed by surgery and continuing with adjuvant treatment using the same experimental agent (The Cancer Letter, July 26, 2024).

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.

July 26, 2024

Vol.50 No.30

By Jacquelyn Cobb and Paul Goldberg

Cancer History Project

Remembering the day 22 years ago when ODAC debated the Iressa quandary

On Sept. 24, 2002, when I showed up at a meeting of the FDA Oncologic Drugs Advisory Committee, I had a pretty good idea that the drug on the agenda—AstraZeneca’s Iressa (gefitinib)—was having a surprising effect on some patients in third-line non-small cell lung cancer.

June 21, 2024

Vol.50 No.25

By Paul Goldberg

ODAC votes unanimously in support of use of randomized data in PI3K inhibitor trials

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ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

FDA seeks consumer representatives for the Oncologic Drugs Advisory Committee

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

Remembering the day 22 years ago when ODAC debated the Iressa quandary

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ODAC votes unanimously in support of use of randomized data in PI3K inhibitor trials

YOU MAY BE INTERESTED IN

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitorsVote may lead to rollback of some indications held by BMS and Merck

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitorsVote applies across drugs and indications

FDA seeks consumer representatives for the Oncologic Drugs Advisory Committee

Of adaptive and factorial designsA biostatistician’s interpretation of last week’s ODAC

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

Remembering the day 22 years ago when ODAC debated the Iressa quandary

Never miss an issue!

Login

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC