FDA Update
Recent FDA Approvals in Lymphoma and in Rarer Tumors
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) in combination with lenalidomide and a rituximab product for adults with relapsed or refractory large B-cell lymphoma (LBCL)—including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising ...
FDA Approves First Companion Diagnostic to Identify Patients With Metastatic Breast Cancer Eligible for T-DXd
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with hormone receptor (HR)-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with fam-trastuzumab de...
T-DXd Approved by the FDA for Pretreated Patients With HER2-Low or -Ultralow Metastatic Breast Cancer
The ASCO Post Staff
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridiza...
FDA Approves Acalabrutinib With Bendamustine and Rituximab for Previously Untreated Mantle Cell Lymphoma
The ASCO Post Staff
On January 16, the U.S. Food and Drug Administration (FDA) granted traditional approval to the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem c...
FDA Approves Preparative Regimen for Allogeneic HSCT in Patients With AML or MDS
The ASCO Post Staff
On January 21, the U.S. Food and Drug Administration (FDA) approved treosulfan (Grafapex), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia ...
Accelerated Approval Granted to Zanidatamab-hrii for HER2-Positive Biliary Tract Cancer
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to zanidatamab-hrii (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The FDA also appr...
Oral Liquid Imatinib Approved by the FDA in Leukemia
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) recently has approved an oral solution of the tyrosine kinase inhibitor, imatinib mesylate, called Imkeldi, to treat certain types of leukemia and other cancers. The new solution is an advanced liquid formulation of imatinib designed to provide dosing accu...
Tumor Treating Fields Therapy Receives FDA Approval in Metastatic NSCLC
The ASCO Post Staff
On October 15, 2024, Novocure announced the U.S. Food and Drug Administration (FDA) approval of Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) who have experienced disease progression on or after a...
FDA Approves Perioperative Nivolumab for Resectable NSCLC
The ASCO Post Staff
On October 3, 2024, the U.S. Food and Drug Administration approved nivolumab (Opdivo) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node-positive) non–small cell lu...
Isatuximab Plus VRd Approved by FDA for Newly Diagnosed, Transplant-Ineligible Multiple Myeloma
The ASCO Post Staff
On September 20, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody isatuximab-irfc (Sarclisa) in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). ...
FDA Approves Osimertinib in Stage III NSCLC After Chemoradiotherapy
The ASCO Post Staff
On September 25, the U.S. Food and Drug Administration approved osimertinib (Tagrisso) for adults with locally advanced, unresectable (stage III) non–small cell lung cancer (NSCLC) whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy. These ...
FDA Approves Amivantamab-vmjw With Carboplatin and Pemetrexed for Non–Small Cell Lung Cancer With EGFR Exon 19 Deletions or L858R Mutations
The ASCO Post Staff
On September 19, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substit...
FDA Approves Immunotherapy for Relapsed or Refractory CTCL
The ASCO Post Staff
On August 8, the U.S. Food and Drug Administration (FDA) approved denileukin diftitox-cxdl (Lymphir), a novel immunotherapy for the treatment of adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who have received at least one prior systemic therapy. Denileukin diftitox is t...
FDA Approves IDH1/2 Inhibitor for Certain Patients With Astrocytoma or Oligodendroglioma
The ASCO Post Staff
The U.S. Food and Drug Administration (FDA) has approved vorasidenib (Voranigo), an isocitrate dehydrogenase-1 (IDH1) and -2 (IDH2) inhibitor, for adult and pediatric patients aged 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following su...
FDA Grants Accelerated Approval to Repotrectinib for NTRK Fusion–Positive Solid Tumors
The ASCO Post Staff
On June 13, the U.S. Food and Drug Administration (FDA) granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients aged 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where...
FDA Approves Selpercatinib for RET Fusion–Positive Thyroid Cancer
The ASCO Post Staff
On June 12, the U.S. Food and Drug Administration (FDA) granted traditional approval to selpercatinib (Retevmo) for adult and pediatric patients aged 2 years and older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and whose disease is radioactive iodine–...
FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Mantle Cell Lymphoma
The ASCO Post Staff
On May 30, the U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruto...
FDA Grants Accelerated Approval to Lisocabtagene Maraleucel for Relapsed or Refractory Follicular Lymphoma
The ASCO Post Staff
On May 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic thera...
FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma
The ASCO Post Staff
On February 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for adult patients with unresectable or metastatic melanoma who were previously treated with a PD-1 blocking antibody, or, if they have B...
Alectinib Approved as Adjuvant Treatment for ALK-Positive Non–Small Cell Lung Cancer
The ASCO Post Staff
On April 18, the U.S. Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor alectinib (Alecensa) for adjuvant treatment after tumor resection in patients with ALK-positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. Alectinib is an orally bioavailable...
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...
