FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.

July 26, 2024

Vol.50 No.30

By Jacquelyn Cobb and Paul Goldberg

Clinical Roundup

CD5 deletion enhances the antitumor activity of adoptive T-cell therapies

A new study details the critical influence of CD5, a key immunomodulatory protein, on engineered T-cell therapies, which is the foundational basis of the clinical-stage cell therapy company Vittoria Biotherapeutics’ proprietary Senza5TM platform.

July 26, 2024

Vol.50 No.30

Drugs & Targets

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.

July 26, 2024

Vol.50 No.30

Drugs & Targets

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

FDA cleared the investigational new drug application for ZW191, a novel folate receptor-α targeted topoisomerase I inhibitor antibody-drug conjugate sponsored by Zymeworks.

July 26, 2024

Vol.50 No.30

Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.

July 19, 2024

Vol.50 No.29

By Jacquelyn Cobb

Conversation with The Cancer Letter

Infections are a major cause of death in patients treated with CAR T-cell therapy
Meta-analysis focused on causes of death, excluding relapse, recurrence

More than half of deaths that are not attributed to disease progression or recurrence after CAR T-cell therapy are caused by infections—an unprecedented finding that experts say marks a shift from a conventional focus on mitigating treatment-specific adverse events to including prevention and management of infections.

July 12, 2024

Vol.50 No.28

By Matthew Bin Han Ong

FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

YOU MAY BE INTERESTED IN

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

CD5 deletion enhances the antitumor activity of adoptive T-cell therapies

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

Infections are a major cause of death in patients treated with CAR T-cell therapy
Meta-analysis focused on causes of death, excluding relapse, recurrence

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FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

YOU MAY BE INTERESTED IN

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

CD5 deletion enhances the antitumor activity of adoptive T-cell therapies

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

Platinum drugs are off the shortage list, but the underlying problem is unsolvedFDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

Infections are a major cause of death in patients treated with CAR T-cell therapyMeta-analysis focused on causes of death, excluding relapse, recurrence

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Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

Infections are a major cause of death in patients treated with CAR T-cell therapy
Meta-analysis focused on causes of death, excluding relapse, recurrence