Fam-Trastuzumab Deruxtecan-nxki Approved for Treatment of Breast Cancer

The FDA has approved fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo, Inc.) for treatment of patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer. The approval is specific to individuals who have had prior treatment with an anti–HER2-based regimen in the metastatic, neoadjuvant, or adjuvant setting and have developed disease recurrence within six months of completing therapy. "Although HER2-targeted therapies have improved dise...

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Axicabtagene Ciloleucel Approved for Second-Line Treatment of Large B-Cell Lymphoma

The FDA has approved axicabtagene ciloleucel (Yescarta®, Kite Pharma, Inc.) for treatment of adult patients with large B-cell lymphoma (LBCL). Axicabtagene ciloleucel, also known as axi-cel, is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. It is indicated as a second-line treatment for patients who have already undergone first-line chemoimmunotherapy with no response or who have experienced relapse within 12 months of first-line chemoimmunotherapy. It is noted that axic...

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Lutetium-177-PSMA-617 Approved for Treatment of Metastatic Castration-Resistant Prostate Cancer

The FDA has approved lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) (Pluvicto™, Advanced Accelerator Applications, Novartis) for the treatment of patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) who have undergone treatment with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. In addition, the FDA approved gallium-68 gozetotide (68Ga-PSMA-11) (Locametz®, Novartis), a radioactive diagnostic agent ...

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The Groundbreaking Approval of Tebentafusp for Uveal Melanoma With Richard Carvajal, MD

Richard Carvajal, MD.

Recently, the FDA granted approval to tebentafusp for the treatment of patients with human leukocyte antigen (HLA)-A*02:01–positive unresectable or metastatic uveal melanoma, marking the first agent to be approved for this rare ocular malignancy. In this interview, Dr. Richard Carvajal, Associate Professor of Medicine at Columbia University Irving Medical Center and editorial board member of Oncology Data Advisor, discusses the practice-changing significance of the approval of tebentafusp and delves further into future directions in the development of treatments for uveal melanoma.  

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Pembrolizumab Approved for Treatment of Advanced Endometrial Carcinoma

The FDA has approved pembrolizumab (Keytruda®, Merck) as a monotherapy for patients with advanced endometrial carcinoma that is microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression subsequent to systemic therapy and are not eligible for curative therapy or radiation. In addition, the FDA also approved the VENTANA MMR RxDx Panel (Ventana Medical Systems, Roche Tissue Diagnostics) to be used as a companion diagnostic device for selecting eligible...

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Pacritinib Approved for Intermediate- or High-Risk Myelofibrosis With Thrombocytopenia

The FDA has approved pacritinib (VonjoTM, CTI BioPharma) for the treatment of adult patients with intermediate- to high-risk primary or secondary myelofibrosis with a platelet count below 50x109/L. Pacritinib is a novel oral kinase inhibitor which inhibits Janus kinase 2 (JAK2) with minimal myelosuppression. Previous treatments available for intermediate- and high-risk myelofibrosis have not been approved for patients with severe cytopenia. "Pacritinib can provide a treatment option for patients...

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FDA Approves Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma

The FDA has approved ciltacabtagene autoleucel (CarvyktiTM, Janssen Biotech) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. "Ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell therapy with 2 B-cell maturation antigen (BCMA)–targeting single-domain antibodies, demonstrated early, dee...

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FDA Approves Tebentafusp-Tebn for Uveal Melanoma

The FDA has approved tebentafusp-tebn (Kimmtrak®, Immunocore) for the treatment of patients with HLA-A*02:01–positive unresectable or metastatic uveal melanoma."Uveal melanoma is a disease that is distinct from cutaneous melanoma, with a low tumor mutational burden and a one-year overall survival of approximately 50% in patients with metastatic uveal melanoma," wrote Paul Nathan, MD, PhD, Consultant Medical Oncologist at the Mount Vernon Cancer Centre in the United Kingdom, and colleagues in the...

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The Significance of nab-Sirolimus and Future Directions in the Treatment of Perivascular Epithelioid Cell Tumor (PEComa): Richard F. Riedel, MD

Recently, the FDA granted approval to nanoparticle albumin-bound sirolimus (nab-sirolimus) for the treatment of patients with metastatic malignant perivascular epithelioid cell tumor (PEComa). Dr. Richard F. Riedel, Associate Professor of Medicine at Duke University, was one of the investigators of the AMPECT study, on which the approval was based. In this interview, Dr. Riedel speaks with Oncology Data Advisor about the significance of the approval of nab-sirolimus for the treatment of patients...

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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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