FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors

An overlooked immune cell population may offer new direction for cell and gene therapy

Cell and gene therapies have made incredible strides over the past decade. The 2024 FDA approvals of the first T-cell receptor therapy for the treatment of metastatic synovial sarcoma and the first tumor-infiltrating lymphocyte therapy for the treatment of unresectable or metastatic melanoma mark a significant turning point for solid tumor treatment.xxx:more

Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

The Pazdurs in their garden with their dog, Cleo. The dog’s full name is Cleopatra, Queen of Denial.In 1999, Rick Pazdur went in for a “perfunctory” final interview at FDA. Thinking it would only take a few minutes, his wife, Mary, decided to wait and have a quick cup of coffee at a nearby restaurant—Hooters.

In the name of “radical transparency,” FDA touts publication of 200 complete response letters

In a move advertised as being in line with FDA’s goal of “radical transparency,” the agency July 10 announced the publication of more than 200 complete response letters.

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

FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors

YOU MAY BE INTERESTED IN

An overlooked immune cell population may offer new direction for cell and gene therapy

Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

In the name of “radical transparency,” FDA touts publication of 200 complete response letters

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

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FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors

YOU MAY BE INTERESTED IN

An overlooked immune cell population may offer new direction for cell and gene therapy

Rick and Mary Pazdur on facing “the other side of the stethoscope”A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

In the name of “radical transparency,” FDA touts publication of 200 complete response letters

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

Never miss an issue!

Login

Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology