FDA grants priority review to odronextamab for R/R follicular lymphoma and R/R diffuse large B-cell lymphoma

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

In Brief

Kristi Hendriks joins Lymphoma Research Foundation board of directors

Kristi Hendriks has been elected to the Lymphoma Research Foundation’s board of directors. Hendriks is an entrepreneur, philanthropist, and wife of Boston Red Sox player and cancer survivor Liam Hendriks.

July 26, 2024

Vol.50 No.30

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

FDA grants priority review to odronextamab for R/R follicular lymphoma and R/R diffuse large B-cell lymphoma

YOU MAY BE INTERESTED IN

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

Kristi Hendriks joins Lymphoma Research Foundation board of directors

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.”

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FDA grants priority review to odronextamab for R/R follicular lymphoma and R/R diffuse large B-cell lymphoma

YOU MAY BE INTERESTED IN

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

Kristi Hendriks joins Lymphoma Research Foundation board of directors

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.”

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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.”