FDA approves Abecma for earlier lines of treatment for MM

Jessica Zeller named director of the Office of Compliance and Enforcement, FDA Center for Tobacco Products

Jessica Zeller was named director of the Office of Compliance and Enforcement at the FDA Center for Tobacco Products.

October 23, 2026

OU receives $2.9M NCI grant to study opaganib to enhance CAR T-cell therapy in multiple myeloma

A University of Oklahoma physician-researcher recently received $2.9 million in funding from NCI to study whether RedHill Biopharma’s drug opaganib, given after CAR T-cell therapy, can help the immune cells fight cancer more effectively.

October 23, 2026

Vol.52 No.39

Clinical Roundup

Novel CAR T therapy for r/r MM shows deep and durable responses, phase I study finds

An investigational CAR T therapy can lead to deep and durable responses in people with relapsed/refractory multiple myeloma, according to a phase I clinical trial led by investigators at Mass General Brigham Cancer Institute and the University of Chicago Medicine Comprehensive Cancer Center.

October 23, 2026

Vol.52 No.39

Drugs & Targets

FDA approves pembro or pembro + berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication

FDA has granted a traditional approval to pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high [≥13 mutations/megabase] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

October 23, 2026

Vol.52 No.39

Drugs & Targets

FDA approves bepirovirsen, first-of-its-kind chronic hepatitis B treatment

FDA has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor therapy in adult patients without cirrhosis, receiving Nrtl therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid, and with hepatitis B virus surface antigen levels ≤3000 IU/ml, as determined by an FDA-authorized test.

October 23, 2026

Vol.52 No.39

Drugs & Targets

FDA clears TumorSight Risk, an AI-powered, MRI-derived breast cancer recurrence risk assessment

FDA has cleared TumorSight Risk, an AI-powered, MRI-derived prognostic tool for assessing breast cancer recurrence risk.

October 23, 2026

Vol.52 No.39

FDA approves Abecma for earlier lines of treatment for MM

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Jessica Zeller named director of the Office of Compliance and Enforcement, FDA Center for Tobacco Products

OU receives $2.9M NCI grant to study opaganib to enhance CAR T-cell therapy in multiple myeloma

Novel CAR T therapy for r/r MM shows deep and durable responses, phase I study finds

FDA approves pembro or pembro + berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication

FDA approves bepirovirsen, first-of-its-kind chronic hepatitis B treatment

FDA clears TumorSight Risk, an AI-powered, MRI-derived breast cancer recurrence risk assessment

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