Story · Medicine & Biotech
FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
1 outlet · first reported by FDA Drug Safety / Drugs feed 5d ago · latest 1d ago · 91 hours of coverage
Coverage, in order
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5d agoFDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
Oncology Burst: FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
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2d agoFDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer
FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer
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2d agoFDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation
The Food and Drug Administration granted accelerated approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.
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2d agoFDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
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2d agoFDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
On May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
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2d agoFDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
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2d agoFDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma
On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor.
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2d agoFDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma
FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma
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1d agoFDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
On November 8, 2024, the Food and Drug Administration approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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1d agoFDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation
On November 15, 2024, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
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1d agoFDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients
On December 18, 2024, the Food and Drug Administration approved remestemcel-L-rknd (Ryoncil, Mesoblast, Inc.), an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients 2 months of age and older.
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1d agoFDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma
On January 19, 2023, the Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa, BeiGene USA, Inc.) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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1d agoFDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy
On August 1, 2024, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer (EC).
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1d agoFDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
On June 21, 2024, the FDA granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc.) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test.
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1d agoFDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia
On October 29, 2024, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
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1d agoFDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis
On January 15, 2021, the Food and Drug Administration granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) amyloidosis.
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1d agoFDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors
FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic device to select patients with dMMR solid tumors for treatment with dostarlimab-gxly.
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1d agoFDA grants accelerated approval to elranatamab-bcmm for multiple myeloma
FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma
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