FDA issues draft guidance on conducting multiregional clinical trials in oncology

Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
An oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, was named director of the FDA Center for Biologics Evaluation and Research, where he will be responsible for the agency’s regulation of vaccines and biologics, including cell and gene therapies.

May 09, 2025

Vol.51 No.18

By Claire Marie Porter

Cancer Policy

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

Scott GottliebMark B. McClellanTwo former FDA commissioners—Scott Gottlieb and , Mark B. McClellan—

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

FDA announced a meeting of the Oncologic Drugs Advisory Committee May 20 and 21. It will be the first ODAC meeting since President Trump was inaugurated.

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

Positive high-level results from the POTOMAC phase III trial showed one year of treatment with Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk non-muscle-invasive bladder cancer compared to BCG induction and maintenance therapy alone.

May 09, 2025

Vol.51 No.18

Drugs & Targets

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent LGSOC

FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

May 09, 2025

Vol.51 No.18

Clinical

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

When Kelly Spill was eight months pregnant, she experienced some constipation and noticed blood in her stool. Her OBGYN wasn’t worried.

May 02, 2025

Vol.51 No.17

By Jacquelyn Cobb

FDA issues draft guidance on conducting multiregional clinical trials in oncology

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Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
An oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent LGSOC

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

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FDA issues draft guidance on conducting multiregional clinical trials in oncology

YOU MAY BE INTERESTED IN

Cyber-iconoclast Vinay Prasad named head of FDA’s CBERAn oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent LGSOC

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertileSix years later, she is well—and pregnant with her third child

Never miss an issue!

Login

Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
An oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child