FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation
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On November 15, 2024, the FDA granted approval for revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor intended for relapsed or refractory acute leukemia characterized by a lysine methyltransferase 2A gene (KMT2A) translocation in both adult and pediatric patients aged 1 year and older.
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11/15/2024 |
FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
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On November 8, 2024, FDA provided approval to obecabtagene autoleucel (Aucatzyl, Autolus Inc.), which is a CD19-directed genetically modified autologous T cell immunotherapy, designated for adult patients contending with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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11/8/2024 |
FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia
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On October 29, 2024, the FDA expedited approval for asciminib (Scemblix, Novartis AG) for adult patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in its chronic phase (CP).
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10/29/2024 |
FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma
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On October 18, 2024, the FDA sanctioned zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), which is a claudin 18.2 (CLDN18.2)-targeted cytolytic antibody, to be administered alongside fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for adults with advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.
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10/18/2024 |
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
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On October 10, 2024, the FDA approved inavolisib (Itovebi, Genentech, Inc.) in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive (HR-positive), HER2-negative breast cancer that displays resistance following adjuvant endocrine therapy.
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10/10/2024 |
FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
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On October 3, 2024, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) to be used in conjunction with platinum-doublet chemotherapy for neoadjuvant preparations, followed by single-agent nivolumab as adjuvant treatment for confirmed cases of resectable non-small cell lung cancer (NSCLC).
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10/3/2024 |
