i3 Health and Oncology Data Advisor Announce ODACon 2022, a Rare Hematologic Malignancies Symposium

ROCHELLE PARK, NJ—January 12, 2022 – i3 Health and Oncology Data Advisor have announced that ODACon, a Rare Hematologic Malignancies Symposium, will be held on January 29, 2022. This 1-day virtual conference features 5 exclusive sessions on emerging data in hematologic malignancies, including acute lymphoblastic leukemia (ALL), Hodgkin lymphoma (HL), mantle cell lymphoma (MCL), myelodysplastic syndromes (MDS), and Waldenstrom macroglobulinemia (WM), all presented by expert faculty. Attendees can...

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FDA Approves Pembrolizumab for Adjuvant Treatment of Stage IIB or IIC Melanoma

The FDA has approved pembrolizumab (Keytruda®, Merck), a programmed death cell death protein 1 (PD-1)–blocking antibody, for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB or IIC melanoma following complete resection. "Current standard of care for patients after resection of high-risk stage II melanoma is observation," wrote Jason Luke, MD, Director of the Cancer Immunotherapeutics Center in the Division of Hematology/Oncology at the University of Pittsb...

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FDA Approves Daratumumab Plus Hyaluronidase-Fihj, Carfilzomib, and Dexamethasone for Multiple Myeloma

The FDA has approved daratumumab plus hyaluronidase-fihj (Darlazex Faspro®, Janssen Biotech) in combination with carfilzomib (Kyprolis®, Amgen) plus dexamethasone for patients with relapsed/refractory multiple myeloma who had received 1 to 3 prior lines of therapy. "Daratumumab is a human immunoglobulin G kappa monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action," wrote Ajai Chari, MD, Professor of Medicine, Hematology, and Medical Oncology at ...

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FDA Approves Sirolimus Protein-Bound for Perivascular Epithelioid Cell Tumors

The FDA has approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro™, Aadi Bioscience) for patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor. "Malignant perivascular epithelioid cell tumor is a rare, aggressive sarcoma," wrote Andrew J. Wagner, MD, PhD, Medical Director of Ambulatory Oncology at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School, and colleagues, in t...

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FDA Approves Single-Agent Pembrolizumab as Adjuvant Therapy for Renal Cell Carcinoma

The FDA has approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy with resection of metastatic lesions."Patients with renal cell carcinoma who undergo nephrectomy [had] no options for adjuvant therapy to reduce the risk of recurrence that have high levels of supporting evidence [prior to this approval]," wrote Toni K. Choueiri, MD, Director of the Ki...

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FDA Approves Ropeginterferon Alfa-2b-Njft for Polycythemia Vera

The FDA has approved ropeginterferon alfa-2b-njft (Besremi®, PharmaEssentia) for patients with polycythemia vera, marking the first approval of interferon therapy specifically for patients with polycythemia vera and the first treatment for all patients with polycythemia vera, regardless of their prior treatment history. "Ropeginterferon alfa-2b is a novel long-acting monopegylated IFN-alpha-2b," wrote Heinz Gisslinger, MD, Professor of Hematology at the Medical University of Vienna, Austria, and...

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FDA Approves Asciminib for Patients With Chronic Myeloid Leukemia

The FDA has granted accelerated approval to asciminib (Scemblix®, Novartis AG) for patients with Philadelphia chromosome–positive (Ph-positive) chronic myeloid leukemia (CML) who have disease in chronic phase and were previously treated with two or more tyrosine kinase inhibitors and for those whose disease is in chronic phase with the T315I mutation."Patients with CML in chronic phase CML resistant or intolerant to ≥2 tyrosine kinase inhibitors (TKIs) are at high risk of experiencing poor outco...

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FDA Approves Atezolizumab for Non–Small Cell Lung Cancer

The FDA has granted approval to atezolizumab (Tecentriq®, Genentech) for the adjuvant treatment of patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have a programmed death ligand 1 (PD-L1) expression on ≥1% of tumor cells. Atezolizumab is approved for use following resection and platinum-based chemotherapy in this patient population.The FDA has also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems), a diagnostic device that will select patients with...

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FDA Approves Pembrolizumab Combination for Cervical Cancer

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1). The FDA has also granted regular approval to single-agent pembrolizumab for patients with recurrent or metastatic cervical cancer whose tumors express PD-L1, with a combined positive score of ≥1, who experienced disease progression on or after c...

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Abemaciclib Plus Endocrine Therapy Approved for Early Breast Cancer

The FDA has approved abemaciclib (Verzenio®, Eli Lilly and Company) in combination with endocrine therapy consisting of an aromatase inhibitor or tamoxifen as adjuvant therapy for patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive early breast cancer with a high risk of recurrence. Abemaciclib, the first CDK4/6 inhibitor to be approved in the adjuvant breast cancer setting, is indicated for patients with a Ki-67 score of ≥20%. In...

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Brexucabtagene Autoleucel Approved: Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

The FDA has approved brexucabtagene autoleucel (TecartusTM, Kite Pharma), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). "Despite treatment with novel therapies and allogeneic stem cell transplant consolidation, outcomes in adult patients with relapsed or refractory B-cell precursor ALL remain poor, underlining the need for more effective therapies," wrote Bijal D. Shah, MD, Ass...

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FDA Approves Cetuximab Plus Encorafenib for Metastatic Colorectal Cancer

 The FDA has granted approval to cetuximab (Erbitux®, Eli Lilly), in combination with encorafenib (Braftovi®, Array BioPharma) for the treatment of patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. "Patients with metastatic colorectal cancer with the BRAF V600E mutation have a poor prognosis, with a median overall survival of 4 to 6 months after failure of initial therapy," wrote Scott Kopetz, MD, PhD, FACP, Professor in the Department of Gastrointestinal Medical ...

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FDA Approves Ruxolitinib for Chronic Graft-Versus-Host Disease

The FDA has approved ruxolitinib (Jakafi®, Incyte) for adult and pediatric patients 12 year of age and older with chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy."Chronic graft-versus-host disease, a major complication of allogeneic stem cell transplantation, becomes glucocorticoid-refractory or glucocorticoid-dependent in approximately 50% of patients," wrote Robert Zeiser, MD, Professor and Head of the Tumor Immunology and Immune Modulation at th...

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FDA Approves Cabozantinib for Differentiated Thyroid Cancer

The FDA has granted approval to cabozantinib (Cabometyx®, Exelixis) for the treatment of patients with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)–targeted therapy and who are 12 years of age and older and ineligible or refractory to radioactive iodine."Patients with radioiodine-refractory DTC previously treated with VEGFR-targeted therapy have aggressive disease and no available standa...

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Tisotumab Vedotin Approved for Recurrent/Metastatic Cervical Cancer

The FDA has granted accelerated approval to tisotumab vedotin-tftv (TivdakTM, Seagen) for patients with recurrent or metastatic cervical cancer who experience disease progression on or after chemotherapy. "Few effective second-line treatments exist for women with recurrent or metastatic cervical cancer," wrote Robert Coleman, MD, Chief Scientific Officer of the US Oncology Network, and colleagues, in their publication of results of the phase 2 innovaTV/GOG-3023/ENGOT-cv6 trial, on which the appr...

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FDA Approves Mobocertinib for EGFR Exon 20 Insertion–Mutated NSCLC

The FDA has approved mobocertinib (Exkivity™, Takeda) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.In addition, the FDA has approved the OncomineTM Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to determine eligibility for treatment with mobocertinib."EGFR exon 20 insertion mutations ...

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Zanubrutinib Approved for Relapsed/Refractory Marginal Zone Lymphoma

The FDA has granted accelerated approval to zanubrutinib (Brukinsa®, BeiGene) for the treatment of patients with relapsed/refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. "Marginal zone lymphoma is rare and heterogeneous, and it has been difficult to define optimal therapeutic strategies," wrote Stephen Opat, FRACP, FRCPA, MBBS, Director of Clinical Hematology at Monash Health in Australia, and colleagues, in their publication of the initial results...

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FDA Approves Zanubrutinib for Waldenstrom Macroglobulinemia

The FDA has granted approval to zanubrutinib (Brukinsa®, BeiGene) for the treatment of patients with Waldenstrom macroglobulinemia (WM). "Bruton tyrosine kinase (BTK) inhibition is an emerging standard of care for WM," wrote Constantine Si Lun Tam, MBBS, MD, FRACP, FRCPA, Professor at the Peter MacCallum Cancer Centre in Australia, and colleagues, in their publication of the ASPEN study results (NCT03053440), on which the approval was based. "ASPEN is a randomized phase 3 study comparing zanubru...

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FDA Approves Pembrolizumab for Advanced/Metastatic Urothelial Carcinoma

The FDA has granted regular approval to pembrolizumab (Keytruda®, Merck) for the first-line treatment of patients with locally advanced/metastatic urothelial carcinoma who are ineligible for platinum-containing chemotherapy. This regular approval comes after the FDA granted pembrolizumab accelerated approval. "Programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors are active in metastatic urothelial carcinoma," wrote Thomas Powles, MD, Professor of Genitourinary ...

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Atezolizumab Indication Withdrawn from Triple-Negative Breast Cancer Treatment

In consultation with the FDA, the accelerated approval of atezolizumab (Tecentriq®, Genentech) in combination with nab-paclitaxel has been voluntarily withdrawn from the treatment of patients with programmed death ligand 1 (PD-L1)–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). "Triple-negative breast cancer is a heterogenous disease entity with a high unmet medical need," wrote David Miles, MD, Lead Clinician for Breast Cancer at Mount Vernon Cancer Ce...

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