Elacestrant Approved for ER-Positive, HER2-Negative, ESR1-Mutated Breast Cancer
Lyn Brook
FDA Updates
The FDA has approved elacestrant (Orserdu™, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor 1 (ESR1)–mutated advanced or metastatic breast cancer with disease progression subsequent to at least one line of endocrine t...
Pirtobrutinib Granted Accelerated Approval for Mantle Cell Lymphoma
Lyn Brook
FDA Updates
The FDA has granted accelerated approval to pirtobrutinib (Jaypirca™, Eli Lilly and Company) for patients with relapsed or refractory mantle cell lymphoma (MCL) following a minimum of two lines of systemic therapy that included a Bruton tyrosine kinase inhibitor (BTKi). "Pirtobrutinib, a highly selective, non-covalent (reversible) BTKi, inhibits bo...
Pembrolizumab Approved for Adjuvant Treatment of Non–Small Cell Lung Cancer
Lyn Brook
FDA Updates
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 observat...
Zanubrutinib Approved for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Lyn Brook
FDA Updates
The FDA has approved zanubrutinib (Brukinsa®, BeiGene USA, Inc.) for treatment of chronic lymphocytic leukemia (CLL) and its tissue counterpart, small lymphocytic lymphoma (SLL). "Zanubrutinib is a next-generation, selective Bruton tyrosine kinase inhibitor with efficacy in relapsed CLL and SLL," wrote Constantine Tam, MD, the Director of Hematolog...
Tucatinib Plus Trastuzumab Approved for Colorectal Cancer
Lyn Brook
FDA Updates
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 ch...
FDA Oncology Approvals in 2022: Timeline of Novel Treatment Options
Lyn Brook
FDA Updates
The past year has been filled with new and exciting improvements and novel treatment options in the field of oncology and hematology. The FDA has granted approval and accelerated approval to many new drugs and drug combinations, including the very first approval for patients with HER2-mutant non–small cell lung cancer, trastuzumab deruxtecan. This ...
Mosunetuzumab-axgb Approved for Relapsed/Refractory Follicular Lymphoma
Keira Smith
FDA Updates
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...
Pafolacianine Approved for Detection of Lung Cancer Lesions
Keira Smith
FDA Updates
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 lun...
Nadofaragene Firadenovec-vncg Approved for Non–Muscle-Invasive Bladder Cancer
Lyn Brook
FDA Updates
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 ge...
Adagrasib Approved for KRAS G12C–Mutated Non–Small Cell Lung Cancer
Lyn Brook
FDA Updates
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 sar...
Atezolizumab Approved for Alveolar Soft Part Sarcoma
Lyn Brook
FDA Updates
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, ...
Olutasidenib Approved for Acute Myeloid Leukemia
Lyn Brook
FDA Updates
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 pa...
Mirvetuximab Soravtansine Approved for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
Keira Smith
FDA Updates
The FDA has granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere®, ImmunoGen), a folate receptor alpha (FRα)–directed antibody and microtubule inhibitor conjugate, for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers previously treated with one to three systemic trea...
Tremelimumab Plus Durvalumab and Platinum-Based Chemotherapy Approved for Metastatic NSCLC
Lyn Brook
FDA Updates
The FDA has approved tremelimumab (Imjudo®, AstraZeneca) in combination with durvalumab (Imfinzi®, AstraZeneca) and platinum-based chemotherapy for patients with metastatic non–small cell lung cancer (NSCLC) who have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Tremel...
Cemiplimab-rwlc Approved for Treatment of Non–Small Cell Lung Cancer
Lyn Brook
FDA Updates
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...
Teclistamab Receives Accelerated Approval for Relapsed/Refractory Multiple Myeloma
Keira Smith
FDA Updates
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 ma...
Tremelimumab Plus Durvalumab Approved For Unresectable Hepatocellular Carcinoma
Lyn Brook
FDA Updates
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...
Futibatinib Receives Accelerated Approval for Cholangiocarcinoma
Lyn Brook
FDA Updates
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 ...
Selpercatinib Approved for RET Fusion–Positive Solid Tumors
Lyn Brook
FDA Updates
The FDA has granted accelerated approval to selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion solid tumors that have progressed on prior systemic therapy, or who have no adequate alternative treatment options. "Selpercatinib, a highly ...
Selpercatinib Approved for RET Fusion-Positive Non-Small Cell Lung Cancer
Lyn Brook
FDA Updates
The FDA has granted regular approval selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion non-small cell lung cancer (NSCLC). Selpercatinib previously received an accelerated approval from the FDA based on its initial trial results in May...

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