FDA Update
FDA Approves Nivolumab in Combination With Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma
The ASCO Post Staff
On March 6, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. CheckMate 901 Efficacy was evaluated in CheckMat...
FDA Grants Accelerated Approval to Zanubrutinib Plus Obinutuzumab for Relapsed or Refractory Follicular Lymphoma
The ASCO Post Staff
On March 7, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the small-molecule BTK inhibitor zanubrutinib (Brukinsa) in combination with the anti-CD20 monoclonal antibody obinutuzumab for patients with relapsed or refractory follicular lymphoma after two or more lines of ...
FDA Approves Amivantamab-vmjw for EGFR Exon 20 Insertion–Mutated NSCLC
The ASCO Post Staff
On March 1, the FDA approved the monoclonal bispecific anti–EGFR-MET antibody amivantamab-vmjw (Rybrevant) in combination with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. ...
FDA Approves Irinotecan Liposome as First-Line Treatment of Metastatic Pancreatic Adenocarcinoma
The ASCO Post Staff
On February 13, the U.S. Food and Drug Administration (FDA) approved irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma. NAPOLI-3 Efficacy was evaluated in NAPOLI-3 (ClinicalTrials.gov identifier NCT0408...
FDA Approves Trifluridine and Tipiracil With Bevacizumab for Previously Treated Metastatic Colorectal Cancer
The ASCO Post Staff
On August 2, the U.S. Food and Drug Administration (FDA) approved trifluridine and tipiracil (Lonsurf) with bevacizumab for patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if ...
FDA Approves Olaparib Plus Abiraterone and Prednisone or Prednisolone for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
The ASCO Post Staff
On May 31, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in combination with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-appr...
FDA Approves Polatuzumab Vedotin-piiq Plus R-CHP for Previously Untreated DLBCL–Not Otherwise Specified and High-Grade B-Cell Lymphoma
The ASCO Post Staff
On April 19, the U.S. Food and Drug Administration (FDA) approved the antibody-drug conjugate polatuzumab vedotin-piiq (Polivy) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for previously untreated adult patients who have diffuse large B-cell lymphoma (DLBCL)–not o...
FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
The ASCO Post Staff
On January 27, the U.S. Food and Drug Administration (FDA) approved elacestrant (Orserdu) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine the...
FDA Approves New, Updated Indications for Temozolomide
The ASCO Post Staff
On September 14, the U.S. Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar) for the treatment of CNS cancers under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for older oncology drugs to ensure information ...
Recent FDA Approvals in Breast Cancer
The ASCO Post Staff
Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and expanded indications for older therapeutic agents used in breast cancer. Abemaciclib Plus Endocrine Therapy On March 3, 2023, the FDA expanded the indication for abemaciclib with endocrine t...
FDA Approves Melphalan Hepatic Delivery System for Adult Patients With Unresectable Hepatic-Dominant Metastatic Uveal Melanoma
The ASCO Post Staff
On August 14, the U.S. Food and Drug Administration (FDA) approved the HEPZATO KIT, a melphalan hepatic delivery system, as a liver-directed treatment for adult patients with metastatic uveal melanoma and unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic diseas...
Accelerated Approval for Elranatamab-bcmm in Patients With Relapsed or Refractory Multiple Myeloma
The ASCO Post Staff
On August 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm (Elrexfio), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior line...
Recent FDA Approvals in Hematologic Oncology
The ASCO Post Staff
Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for older therapeutic agents used in hematologic oncology. Glofitamab for DLBCL On June 15, 2023, the FDA granted accelerated approval to glofitamab-gxbm (Columvi) for relaps...
FDA Approves Omidubicel-onlv to Reduce Time to Neutrophil Recovery and Infection in Patients With Hematologic Malignancies
The ASCO Post Staff
On April 17, the U.S. Food and Drug Administration (FDA) approved omidubicel-onlv (Omisirge) for use in adult and pediatric patients aged 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time ...
FDA Approves Sacituzumab Govitecan-hziy for Pretreated Patients With HR-Positive, HER2-Negative Breast Cancer
The ASCO Post Staff
On February 3, the U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable, locally advanced or metastatic, hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+ with a negative in situ hybridizati...
FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
The ASCO Post Staff
On January 27, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca) for patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BRUIN Efficacy was e...
FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
The ASCO Post Staff
On November 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received on...
FDA Approves Oral MEK Inhibitor Cobimetinib for Histiocytic Neoplasms
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) has approved cobimetinib (Cotellic), an oral inhibitor of MEK1 and MEK2, for the treatment of adult patients with the family of blood diseases known as histiocytic neoplasms. These diseases include Erdheim-Chester disease, Rosai-Dorfman disease, and Langer...
FDA Approves Cemiplimab-rwlc in Combination With Platinum-Based Chemotherapy for NSCLC
The ASCO Post Staff
On November 8, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adult patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. Study 16113 Efficacy was eval...
FDA Grants Accelerated Approval to Teclistamab-cqyv for Resistant Myeloma
The ASCO Post Staff
On October 25, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to teclistamab-cqyv (Tecvayli), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four pri...
FDA Grants Accelerated Approval to Futibatinib for Previously Treated Patients With FGFR2-Mutated Cholangiocarcinoma
The ASCO Post Staff
On September 30, the U.S. Food and Drug Administration (FDA) granted accelerated approval to futibatinib (Lytgobi) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or ot...
FDA Approves Selpercatinib for Locally Advanced or Metastatic RET Fusion–Positive NSCLC
The ASCO Post Staff
On September 21, the U.S. Food and Drug Administration (FDA) granted regular approval to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a RET gene fusion (as detected by an FDA-approved test). The FDA also approved the Oncomine...
FDA Approves Pemigatinib for Patients With Myeloid/Lymphoid Neoplasms and FGFR1 Rearrangement
The ASCO Post Staff
On August 26, the U.S. Food and Drug Administration (FDA) approved pemigatinib (Pemazyre), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. Myeloid/lymphoid neoplasms with FGFR...
FDA Approves Sodium Thiosulfate to Reduce the Risk of Ototoxicity Associated With Cisplatin
The ASCO Post Staff
On September 20, the U.S. Food and Drug Administration (FDA) approved sodium thiosulfate (Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized (nonmetastatic) solid tumors. Efficacy was evaluated in two multicenter, open-la...
Recent FDA Approvals in Breast Cancer
The ASCO Post Staff
In the past year, the U.S. Food and Drug Administration (FDA) approved four treatment options for patients with breast cancer, which are summarized herein. T-DXd for HER2-Low Breast Cancer On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu; T-DXd) for adult patients with ...
FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-vs-Host Disease
The ASCO Post Staff
On August 24, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for pediatric patients aged at least 1 year with chronic graft-vs-host disease after failure of one or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. iMAGINE Trial ...
FDA Approves Durvalumab-Based Combination for Locally Advanced or Metastatic Biliary Tract Cancer
The ASCO Post Staff
On September 2, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. TOPAZ-1 Efficacy was evaluated in TOPAZ-1 (ClinicalTrials.gov identifier: NCT03875235...
FDA Approves Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutations
The ASCO Post Staff
On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib (Tabrecta) for adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an ...
FDA Approves Darolutamide for Metastatic Hormone-Sensitive Prostate Cancer
The ASCO Post Staff
On August 5, 2022, the U.S. Food and Drug Administration approved darolutamide (Nubeqa) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer. The evaluation of efficacy was based on ARASENS (ClinicalTrials.gov identifier NCT02799602), a randomize...
FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumors
The ASCO Post Staff
On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori) for adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. Two Trials The safety and ef...
FDA Grants Accelerated Approval to Trastuzumab Deruxtecan for HER2-Mutant NSCLC
The ASCO Post Staff
On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 mutations, as detected by an FDA-ap...
Companion Diagnostic to Identify Patients With Endometrial Cancer Eligible for Pembrolizumab Therapy Approved by the FDA
The ASCO Post Staff
On August 11, 2022, Roche announced the U.S. Food and Drug Administration (FDA) approval of a label expansion for the Ventana MMR RxDx Panel. The Ventana MMR RxDx Panel is the first immunohistochemistry companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA ...
FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer
The ASCO Post Staff
On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth f...
FDA Approves Lisocabtagene Maraleucel for the Second-Line Treatment of Large B-Cell Lymphoma
The ASCO Post Staff
On June 24, the U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) for adult patients with large B-cell lymphoma (LBCL) who have disease refractory to first-line chemoimmunotherapy or relapse within 12 months of fir...
Dabrafenib/Trametinib Combination Receives FDA Approval for BRAF V600E–Mutated Solid Tumors
The ASCO Post Staff
On June 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval for dabrafenib (Tafinlar) plus trametinib (Mekinist) for the treatment of adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors with a BRAF V600E mutation whose disease has...
FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) recently announced the launch of the “Next Legends” Youth E-cigarette Prevention Campaign as part of the agency’s ongoing efforts to protect youth from the dangers of tobacco use. The campaign will educate American Indian/Alaska Native (AI/AN) youth, ages ...
FDA Approves Ivosidenib/Azacitidine for Certain Patients With Newly Diagnosed AML
The ASCO Post Staff
On May 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test in adults aged 75 or older, or who have comorbiditi...
FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia
The ASCO Post Staff
On May 20, the U.S. Food and Drug Administration approved azacitidine (Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). AZA-JMML-001 Efficacy was evaluated in AZA-JMML-001 (ClinicalTrials.gov identifier NCT02447666), an international, multicenter, open-l...
FDA Approves Two Nivolumab-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma
The ASCO Post Staff
On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma: Nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-based chemotherapy Nivolumab in combi...
New FDA-Approved Oncology Drugs (2021–2022)
Compiled by Donna Bell
Over the past year (May 2021–May 2022), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below. FAM-TRASTUZUMAB DERUXTECAN-NX...
FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Breast Cancer
The ASCO Post Staff
On May 4, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for pretreated adult patients with unresectable or metastatic HER2-positive breast cancer. According to the approval, patients had to have received a prior anti-HER2–based regimen either in the m...
FDA Approves Nivolumab/Relatlimab-rmbw for Unresectable or Metastatic Melanoma
The ASCO Post Staff
On March 18, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw (Opdualag) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approved treatment is a fixed-dose combination of the LAG-3–blocking antibody relatlimab ...
FDA Approves Axicabtagene Ciloleucel for the Second-Line Treatment of Large B-Cell Lymphoma
The ASCO Post Staff
On April 1, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta) for adult patients with large B-cell lymphoma (LBCL) who are refractory to first-line chemoimmunotherapy or who experienced relapse within 12 months of first-line chemoimmunotherapy. It is not indicat...
FDA Approves Radioligand for Metastatic Castration-Resistant Prostate Cancer
The ASCO Post Staff
On March 23, the U.S. Food and Drug Administration approved lutetium Lu-177 vipivotide tetraxetan (Pluvicto) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathwa...
FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma
The ASCO Post Staff
On March 21, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair–deficient (as determined by an FDA-approved test). Eligible patients have disease p...
FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer
The ASCO Post Staff
On March 11, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemothe...
FDA Approves Pacritinib for Adult Patients With Myelofibrosis and Thrombocytopenia
The ASCO Post Staff
On February 28, the U.S. Food and Drug Administration (FDA) approved pacritinib (Vonjo) for the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Pacritinib is a no...
FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
The ASCO Post Staff
On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...
Robert M. Califf, MD, MACC, Confirmed as FDA Commissioner
The ASCO Post Staff
On February 15, the Senate voted 50 to 46 to confirm Robert M. Califf, MD, MACC, as Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Califf was previously the Commissioner of the FDA from February 2016 to January 2017. He also served as the FDA’s Deputy Commissioner for Medical Prod...
FDA Approves Tebentafusp-tebn for the Treatment of Unresectable or Metastatic Uveal Melanoma
The ASCO Post Staff
On January 26, the U.S. Food and Drug Administration (FDA) granted approval to tebentafusp-tebn (Kimmtrak) for the treatment of adult patients with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma. Tebentafusp’s approval establishes several firsts: as the first T-cell receptor therap...
