FDA grants orphan drug designation to MB-105 for CD5-targeted CAR T-cell therapy

FDA grants accelerated approval to Zegfrovy for NSCLC with EGFR exon20ins

FDA has approved Zegfrovy (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

July 03, 2025

Vol.51 No.26

Drugs & Targets

FDA grants accelerated approval to linvoseltamab-gcpt for r/r MM

FDA has granted accelerated approval to linvoseltamab-gcpt, trade name Lynozyfic, a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

July 03, 2025

Vol.51 No.26

Drugs & Targets

REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated

FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is no longer necessary to ensure that the benefits of these CAR T-cell immunotherapies outweigh their risks and to minimize the burden on the healthcare delivery system of complying with the REMS.

July 03, 2025

Vol.51 No.26

Cancer Policy

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

FDA grants orphan drug designation to MB-105 for CD5-targeted CAR T-cell therapy

YOU MAY BE INTERESTED IN

FDA grants accelerated approval to Zegfrovy for NSCLC with EGFR exon20ins

FDA grants accelerated approval to linvoseltamab-gcpt for r/r MM

REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated

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

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