Pembrolizumab Approved for Adjuvant Treatment of Non–Small Cell Lung Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) for adjuvant treatment of stage IB, II, or IIIA non–small cell lung cancer (NSCLC), following resection and platinum-based chemotherapy. "Although adjuvant chemotherapy improves overall survival in completely resected NSCLC, the absolute 5-year survival benefit is moderate compared with observation alone," wrote Mary O'Brien, MD, Head of Royal Marsden Hospital's Lung Unit, and colleagues, in their published results of the KEYNOTE-091 trial (N...

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Pafolacianine Approved for Detection of Lung Cancer Lesions

The FDA has approved a new indication for pafolacianine (Cytalux®, On Target Laboratories), a diagnostic agent, for the identification of lung cancer lesions in adult patients with known or suspected lung cancer who are undergoing surgery. Administered intravenously prior to surgery, pafolacianine is designed to locate additional hard-to-detect lung cancerous tissue. The safety and efficacy of pafolacianine were evaluated in the randomized, multicenter, open-label, phase 3 ELUCIDATE trial (NCT04...

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Tucatinib Plus Trastuzumab Approved for Colorectal Cancer

The FDA has granted accelerated approval to tucatinib (Tukysa®, Seagen, Inc.) with trastuzumab for rat sarcoma (RAS) wild-type human epidermal growth factor receptor 2 (HER2)–positive unresectable or metastatic colorectal cancer (CRC) that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. "Patients with chemotherapy-refractory HER2-positive metastatic colorectal cancer receive limited clinical benefit with currently available therapies," said John Stric...

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Mosunetuzumab-axgb Approved for Relapsed/Refractory Follicular Lymphoma

The FDA has granted accelerated approval to mosunetuzumab-axgb (Lunsumio™, Genentech) for adult patients with relapsed or refractory follicular lymphoma (FL) who have previously received at least two lines of systemic therapy. "Mosunetuzumab is a CD20 x CD3 T-cell–engaging bispecific monoclonal antibody that redirects T cells to eliminate malignant B cells," wrote L. Elizabeth Budde, MD, PhD, Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of ...

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Nadofaragene Firadenovec-vncg Approved for Non–Muscle-Invasive Bladder Cancer

The FDA has approved nadofaragene firadenovec-vncg (Adstiladrin®, Ferring Pharmaceuticals) for treatment of high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Nadofaragene firadenovec-vncg is a non-replicating adenoviral vector-based gene therapy that cannot multiply in human cells and the first gene therapy to be approved for high-risk NMIBC. "BCG is the most effective therapy for h...

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Adagrasib Approved for KRAS G12C–Mutated Non–Small Cell Lung Cancer

The FDA has granted accelerated approval to adagrasib (Krazati™, Mirati Therapeutics, Inc.) for treatment of adult patients with kirsten rat sarcoma viral oncogene homologue (KRAS) G12C–mutated locally advanced or metastatic non­–small cell lung cancer (NSCLC). Patients should have received one prior line of systemic therapy. Adagrasib is a rat sarcoma virus (RAS) guanosine triphosphatase (GTPase) family inhibitor. "Adagrasib (MRTX849), a potent, orally available, small molecule covalent inhibit...

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Atezolizumab Approved for Alveolar Soft Part Sarcoma

The FDA has granted approval to atezolizumab (Tecentriq®, Genentech, Inc.) for treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS) in patients two years of age and older. Atezolizumab is an immune checkpoint inhibitor targeting programmed cell death ligand 1 (PD-L1). Safety and efficacy were measured in a phase 2, open-label, single-arm study (NCT03141684) which enrolled 49 patients with histologically or cytologically confirmed ASPS incurable by surgery and an Eastern Coop...

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Olutasidenib Approved for Acute Myeloid Leukemia

The FDA has granted approval to olutasidenib (Rezlidhia™, Rigel Pharmaceuticals Inc.) for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase 1 gene (IDH1) mutation. Additionally, the FDA granted approval to the Abbott RealTime IDH1 Assay to accurately detect and select patients to receive olutasidenib. Olutasidenib is an inhibitor specific to mutant IDH1. "Mutation of IDH1 occurs in 7% to 14% of patients with AML," wro...

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Cemiplimab-rwlc Approved for Treatment of Non–Small Cell Lung Cancer

The FDA has granted approval of cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for treatment of advanced non–small cell lung cancer (aNSCLC) with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) aberrations, and no prior systemic treatment. Cemiplimab-rwlc is a fully human immune checkpoint inhibitor targeting the programmed cell death receptor-1 (PD-1). "Pembrolizumab and ate...

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Teclistamab Receives Accelerated Approval for Relapsed/Refractory Multiple Myeloma

The FDA has granted accelerated approval to teclistamab-cqyv (Tecvayli®, Janssen Biotech) for adult patients with relapsed/refractory multiple myeloma previously treated with four or more lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Teclistimab is the first bispecific B-cell maturation antigen (BCMA)–directed CD3 T-cell engager. "Standard treatment of multiple myeloma includes the administration of immunomodulatory agents, p...

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Tremelimumab Plus Durvalumab Approved For Unresectable Hepatocellular Carcinoma

The FDA has granted approval to tremelimumab (Imjudo®, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). "Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival," remarked Ghassan Abou-Alfa, MD, MBA, an Attending Physician at Memorial Sloan Kettering Cancer Center, and colleagues, regarding the HIMALAYA trial (NCT03298451), on which approval was ...

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The Groundbreaking Approval of Tebentafusp for Uveal Melanoma With 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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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 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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Futibatinib Receives Accelerated Approval for Cholangiocarcinoma

The FDA has granted accelerated approval to futibatinib (Lytgobi®, Taiho Oncology, Inc.) for treatment of previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) with fibroblast growth factor receptor 2 (FGFR2) gene fusions or rearrangements. "Survival outcomes are historically poor in patients with advanced/metastatic iCCA, with median overall survival times of approximately one year with first-line gemcitabine plus cisplatin and approximately si...

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Nivolumab Plus Fluoropyrimidine and Platinum-Based Chemotherapy and Nivolumab Plus Ipilimumab Approved for Esophageal Squamous Cell Carcinoma

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with fluoropyrimidine with platinum-based chemotherapy, and nivolumab in combination with ipilimumab (Yervoy®, Bristol Myers Squibb) for treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). "Esophageal cancer causes more than half a million cancer-related deaths worldwide each year, with squamous cell carcinoma accounting for approximately 85% of cases," wrote Yuichiro Doki, MD, ...

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Darolutamide Approved for Treatment of Metastatic Hormone-Sensitive Prostate Cancer

The FDA has approved darolutamide (Nubeqa®, Bayer HealthCare Pharmaceuticals Inc.) in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). "Standard treatment for patients with metastatic, hormone-sensitive prostate cancer includes the addition of either docetaxel or an androgen-receptor pathway inhibitor to androgen-deprivation therapy," wrote Matthew Smith, MD, PhD, Director of the Genitourinary Malignancies Program at the Massachusetts Gener...

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Durvalumab Approved for Treatment of Biliary Tract Cancer

The FDA has approved durvalumab (Imfinzi®, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for treatment of locally advanced or metastatic biliary tract cancer. "Biliary tract cancer, a heterogeneous group of malignancies that includes intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of Vater cancer, is typically diagnosed at advanced stages, for which curative surgery is not feasible and prognosis is poor," wrote Do-Youn Oh, MD, PhD, Profes...

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Capmatinib Granted Regular Approval for Metastatic Non–Small Cell Lung Cancer

The FDA has granted regular approval to capmatinib (Tabrecta®, Novartis Pharmaceuticals Corp.) for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) who have tumors evolving into the mesenchymal-epithelial transition exon 14 skipping (METex14) mutation. Capmatinib was previously granted accelerated approval in May 2020 based on initial data from the GEOMETRY mono-1 trial (NCT02414139); due to updated results, the FDA is now converting it to regular approval. "Activat...

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Trastuzumab Deruxtecan First Approval for HER2-Mutant Non–Small Cell Lung Cancer

The FDA has granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd) (Enhertu®, Daiichi Sankyo Inc.) for treatment of adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) mutations. This approval is specific to individuals who have undergone previous systemic therapy. Trastuzumab deruxtecan is the first drug to be approved for treatment of HER2-mutant NSCLC. "HER2 mutations are an established molecul...

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