UPenn study supports continued use of ODAC voting

COI statement prohibits “unseemly advocacy,” “undue influence” by industry rep on ODAC

In April, FDA Commissioner Marty Makary said that the presence of industry employees as members of FDA advisory committees “represents a cozy relationship” between FDA and the businesses it regulates.

FDA extends review period for Blenrep combinations after unfavorable ODAC vote, EU approval

FDA July 23 extended the review period for the Biologics License Application for Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population

The FDA Oncologic Drugs Advisory Committee July 17 recommended against approval of a Blenrep-based regimen for the treatment of relapsed or refractory multiple myeloma, citing unacceptable rates of ocular toxicity and overall poor tolerability of the drug.

July 18, 2025

Vol.51 No.28

By Jacquelyn Cobb and Sara Willa Ernst

Podcast

In The Headlines: Back to “business as usual” at FDA?

The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.

May 28, 2025

Vol.51 No.20

Regulatory News

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.

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.

May 09, 2025

Vol.51 No.18

By Jacquelyn Cobb

UPenn study supports continued use of ODAC voting

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COI statement prohibits “unseemly advocacy,” “undue influence” by industry rep on ODAC

FDA extends review period for Blenrep combinations after unfavorable ODAC vote, EU approval

ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population

In The Headlines: Back to “business as usual” at FDA?

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

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

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