FDA accepts supplemental BLAs for two Opdivo regimens

CAR T-cell therapy for B-ALL results in high incidence of durable response in phase I/II study

B-cell acute lymphoblastic leukemia is a common type of ALL in adults.

March 07, 2025

Rusfertide meets primary endpoint in phase III VERIFY trial for patients with polycythemia vera

The phase III VERIFY trial, in which phlebotomy-dependent patients with polycythemia vera were randomized to treatment with either rusfertide (PTG-300) or placebo, as an add-on to standard of care treatment, met its primary endpoint of proportion of patients achieving response.

March 07, 2025

Vol.51 No.09

Drugs & Targets

FDA approves Tevimbra + chemo for advanced ESCC

FDA approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (≥1).

March 07, 2025

Vol.51 No.09

Guest Editorial

Biomarker-driven innovation: What the FDA’s evolving strategy means for oncology

As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments. Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were...

Former CDER Director Patrizia Cavazzoni named Pfizer chief medical officer, executive vice president

Patrizia Cavazzoni will rejoin Pfizer Inc. as chief medical officer and executive vice president.

February 28, 2025

Vol.51 No.08

Drugs & Targets

FDA accepts review for odronextamab BLA in r/r follicular lymphoma

FDA accepted for review the resubmission of the Regeneron Pharmaceuticals, Inc.’s Biologics License Application for Ordspono (odronextamab) in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. The target action date for the FDA decision is July 30.

February 28, 2025

Vol.51 No.08

FDA accepts supplemental BLAs for two Opdivo regimens

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CAR T-cell therapy for B-ALL results in high incidence of durable response in phase I/II study

Rusfertide meets primary endpoint in phase III VERIFY trial for patients with polycythemia vera

FDA approves Tevimbra + chemo for advanced ESCC

Biomarker-driven innovation: What the FDA’s evolving strategy means for oncology

Former CDER Director Patrizia Cavazzoni named Pfizer chief medical officer, executive vice president

FDA accepts review for odronextamab BLA in r/r follicular lymphoma

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