FDA grants Fast Track designation to IO-202, anti-LILRB4 myeloid checkpoint inhibitor for AML

FDA approves Voranigo for grade 2 IDH-mutant glioma

FDA has approved Voranigo (vorasidenib), an isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2 inhibitor, for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.

August 09, 2024

Vol.50 No.32

Drugs & Targets

FDA approves Lymphir immunotherapy for r/r CTCL

FDA has approved Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma after at least one prior systemic therapy.

August 09, 2024

Vol.50 No.32

Drugs & Targets

FDA grants de novo authorization for PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test

Labcorp announced it has received de novo marketing authorization from FDA for PGDx elio plasma focus Dx—the industry’s first and only kitted, pan-solid tumor liquid biopsy test.

August 09, 2024

Vol.50 No.32

Clinical Trials & Tribulations

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

At its most recent meeting, the FDA Oncologic Drugs Advisory Committee focused on perioperative clinical trials, which the agency defined as neoadjuvant phase followed by surgery and continuing with adjuvant treatment using the same experimental agent (The Cancer Letter, July 26, 2024).

Calquence combination significantly improved PFS in CLL in phase III trial

Positive high-level results from an interim analysis of the AMPLIFY phase III trial showed a fixed duration of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia.

August 02, 2024

Vol.50 No.31

Clinical Roundup

Modifying, deleting, or degrading protein ZFP574 reduces division of malignant B cells in lab

Targeting a protein called ZFP574 suppressed leukemia in a mouse model of the disease, UT Southwestern Medical Center researchers showed in a new study. Their findings, published in PNAS, could lead to new treatments for leukemias and lymphomas in cancer patients.

August 02, 2024

Vol.50 No.31

FDA grants Fast Track designation to IO-202, anti-LILRB4 myeloid checkpoint inhibitor for AML

YOU MAY BE INTERESTED IN

FDA approves Voranigo for grade 2 IDH-mutant glioma

FDA approves Lymphir immunotherapy for r/r CTCL

FDA grants de novo authorization for PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

Calquence combination significantly improved PFS in CLL in phase III trial

Modifying, deleting, or degrading protein ZFP574 reduces division of malignant B cells in lab

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FDA grants Fast Track designation to IO-202, anti-LILRB4 myeloid checkpoint inhibitor for AML

YOU MAY BE INTERESTED IN

FDA approves Voranigo for grade 2 IDH-mutant glioma

FDA approves Lymphir immunotherapy for r/r CTCL

FDA grants de novo authorization for PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test

Of adaptive and factorial designsA biostatistician’s interpretation of last week’s ODAC

Calquence combination significantly improved PFS in CLL in phase III trial

Modifying, deleting, or degrading protein ZFP574 reduces division of malignant B cells in lab

Login

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC