Olaparib Approved With Abiraterone and Prednisone, or Prednisolone, for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Lyn Brook
FDA Updates
The FDA has granted approval to olaparib (Lynparza®, AstraZeneca Pharmaceuticals) with abiraterone and either prednisone or prednisolone for treatment of deleterious or suspected deleterious breast cancer gene–mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as detected by an FDA-approved companion diagnostic test.   Wh...
Epcoritamab-bysp Approved for Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma
Lyn Brook
FDA Updates
The FDA has approved epcoritamab-bysp (Epkinly™, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified. This approval includes high-grade B-cell lymphoma after two or more lines of systemic therapy and DLBCL arising from indolent lymphoma.   Why it matters: "Treatment regimens incorporating ...
Polatuzumab Vedotin Approved for Previously Untreated Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, and High-Grade B-Cell Lymphoma
Lyn Brook
FDA Updates
The FDA has approved polatuzumab vedotin-piiq (Polivy®, Genentech, Inc.) plus R-CHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) for adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL); including those who have an International Prognostic I...
Omidubicel-onlv Approved for Reducing Infection and Time to Neutrophil Recovery in Patients With Hematologic Malignancies
Lyn Brook
FDA Updates
The FDA has approved omidubicel-onlv (Omisirge®, Gamida Cell Ltd.) for treatment of adult and pediatric patients 12 and older with hematologic malignancies, to minimize the time to neutrophil recovery and incidence of infection following myeloablative conditioning for umbilical cord transplantation. Approved population: adults and pediatric pa...
Enfortumab Vedotin Plus Pembrolizumab Approved For Urothelial Carcinoma
Lyn Brook
FDA Updates
The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) with pembrolizumab (Keytruda®, Merck) for treatment of locally advanced or metastatic urothelial carcinoma, specifically for patients who are ineligible for cisplatin-containing chemotherapy. "Both enfortumab vedotin and pembrolizumab are effective monoth...
Retifanlimab Granted Accelerated Approval for Metastatic/Recurrent Merkel Cell Carcinoma
Keira Smith
FDA Updates
The FDA has granted accelerated approval to retifanlimab-dlwr (Zynyz™, Incyte), a programmed cell death protein 1 (PD-1)–blocking antibody, for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). "Retifanlimab is a humanized, hinge-stabilized immunoglobulin G4 kappa (IgG4κ) anti–PD-1 monoclonal antibody with sa...
Dabrafenib Plus Trametinib Approved for Pediatric BRAF V600E–Mutated Low-Grade Glioma
Lyn Brook
FDA Updates
The FDA has granted approval to dabrafenib (Tafinlar®, Novartis) with trametinib (Mekinist®, Novartis) for treatment of pediatric patients with BRAF V600E–mutated low-grade glioma (LGG) who require systemic therapy. In addition, the FDA approved new oral formulations of dabrafenib and trametinib for patients who cannot swallow pills. This is notabl...
Abemaciclib With Endocrine Therapy Receives Expanded Approval for Early Breast Cancer
Lyn Brook
FDA Updates
The FDA has granted approval to abemaciclib (Verzenio®, Eli Lilly and Company) with endocrine therapy—tamoxifen or an aromatase inhibitor—for treatment of adult patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive early breast cancer that is at a high risk of recurrence. Patients cons...
Dostarlimab-gxly Approved For dMMR Endometrial Cancer
Lyn Brook
FDA Updates
The FDA has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for treatment of mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen or who are not eligible for curative surgery or radiation. Diagnosis is determined by an FDA-approved test. "Endometr...
Sacituzumab Govitecan-hziy Approved for HR-Positive Breast Cancer
Lyn Brook
FDA Updates
The FDA has granted approval to sacituzumab govitecan-hziy (Trodelvy®, Gilead Sciences, Inc.) for treatment of unresectable, locally advanced, or metastatic hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer. Patients are required to have received at least one prior line of endocrine therapy and t...
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...

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