Mifepristone and the Administrative Procedure Act: Perspective of a former FDA commissioner and NCI director

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).

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

FDA has granted an accelerated approval to afamitresgene autoleucel (Tecelra), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

August 02, 2024

Vol.50 No.31

Drugs & Targets

FDA approves Darzalex Faspro combination for MM

FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomid, and dexamethasone (D-VRd) for induction and consolidation in patients with newly-diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.

August 02, 2024

Vol.50 No.31

Mifepristone and the Administrative Procedure Act: Perspective of a former FDA commissioner and NCI director

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

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

FDA approves Darzalex Faspro combination for MM

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Mifepristone and the Administrative Procedure Act: Perspective of a former FDA commissioner and NCI director

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

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

FDA approves Darzalex Faspro combination for MM

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