FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

Jacqueline Corrigan-Curay to retire as acting head of CDER at FDA

Jacqueline Corrigan-Curay, the acting director of the Center for Drug Evaluation and Research wrote in an email to colleagues that she will be retiring from the agency in July.

June 27, 2025

Vol.51 No.25

By Claire Marie Porter

Drugs & Targets

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated NSCLC

FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.

June 27, 2025

Vol.51 No.25

Drugs & Targets

FDA grants Breakthrough Therapy designation for daraxonrasib in pancreatic cancer

FDA has granted Breakthrough Therapy Designation to daraxonrasib, a RAS(ON) multi-selective inhibitor, for previously treated metastatic PDAC in patients with KRAS G12 mutations.

June 27, 2025

Vol.51 No.25

Clinical Trials & Tribulations

Optimizing dosing of expensive and toxic oncology drugs: Making America healthier

There is general agreement that the United States spends too much on health care, especially on pharmaceuticals. But what we spend on drugs is not simply a function of price. If eggs double in price, people can simply cut the number of eggs they eat in half. Simply stated, cost is the product of (price per unit times the number of units purchased).

June 20, 2025

Vol.51 No.24

By Mark J. Ratain, David A. Hyman, Jill E. Feldman, Beth R. Jacobson and Allen S. Lichter

Cancer Policy

FDA to issue “national priority vouchers” to companies supporting U.S. interests

A new FDA voucher program will aim to accelerate review time for applications that are deemed to be advancing U.S. “national priorities.”

June 20, 2025

Vol.51 No.24

By Claire Marie Porter

Cancer Policy

Vinay Prasad named chief medical and scientific officer at FDA

Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, who was named director of the FDA Center for Biologics Evaluation and Research in early May (The Cancer Letter, May 9, 2025), has now been also appointed chief medical and science officer at FDA, according to an internal memo obtained by The Cancer Letter.

June 20, 2025

Vol.51 No.24

By Claire Marie Porter

FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

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Jacqueline Corrigan-Curay to retire as acting head of CDER at FDA

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated NSCLC

FDA grants Breakthrough Therapy designation for daraxonrasib in pancreatic cancer

Optimizing dosing of expensive and toxic oncology drugs: Making America healthier

FDA to issue “national priority vouchers” to companies supporting U.S. interests

Vinay Prasad named chief medical and scientific officer at FDA

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