FDA approves nivolumab for adjuvant treatment of stage 2B/C melanoma

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).

March 21, 2025

Vol.51 No.11

Drugs & Targets

FDA grants Orphan Drug designation to rhenium obisbemeda for leptomeningeal metastases in lung cancer

FDA granted Orphan Drug designation to rhenium obisbemeda (186Re) for the treatment of leptomeningeal metastases in patients with lung cancer.

March 14, 2025

Vol.51 No.10

Clinical Roundup

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

Vol.51 No.09

Clinical Roundup

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...

February 28, 2025

Vol.51 No.08

By Harpreet Singh

FDA approves nivolumab for adjuvant treatment of stage 2B/C melanoma

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FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA grants Orphan Drug designation to rhenium obisbemeda for leptomeningeal metastases in lung cancer

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

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FDA approves nivolumab for adjuvant treatment of stage 2B/C melanoma

YOU MAY BE INTERESTED IN

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA grants Orphan Drug designation to rhenium obisbemeda for leptomeningeal metastases in lung cancer

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

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)