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FDA Update

Lymphoma

FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Mantle Cell Lymphoma

The ASCO Post Staff  /  June 10, 2024

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...

Lymphoma
Immunotherapy

FDA Grants Accelerated Approval to Lisocabtagene Maraleucel for Relapsed or Refractory Follicular Lymphoma

The ASCO Post Staff  /  June 10, 2024

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...

Skin Cancer
Immunotherapy

FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma

The ASCO Post Staff  /  May 10, 2024

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...

Lung Cancer

Alectinib Approved as Adjuvant Treatment for ALK-Positive Non–Small Cell Lung Cancer

The ASCO Post Staff  /  May 10, 2024

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...

Bladder Cancer

FDA Approves Nivolumab in Combination With Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma

The ASCO Post Staff  /  March 25, 2024

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...

Lymphoma

FDA Grants Accelerated Approval to Zanubrutinib Plus Obinutuzumab for Relapsed or Refractory Follicular Lymphoma

The ASCO Post Staff  /  March 25, 2024

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 ...

Lung Cancer
Genomics/Genetics

FDA Approves Amivantamab-vmjw for EGFR Exon 20 Insertion–Mutated NSCLC

The ASCO Post Staff  /  March 25, 2024

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. ...

Pancreatic Cancer

FDA Approves Irinotecan Liposome as First-Line Treatment of Metastatic Pancreatic Adenocarcinoma

The ASCO Post Staff  /  March 10, 2024

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...

Colorectal Cancer

FDA Approves Trifluridine and Tipiracil With Bevacizumab for Previously Treated Metastatic Colorectal Cancer

The ASCO Post Staff  /  August 25, 2023

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 ...

Prostate Cancer

FDA Approves Olaparib Plus Abiraterone and Prednisone or Prednisolone for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

The ASCO Post Staff  /  June 25, 2023

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...

Lymphoma
Immunotherapy

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  /  May 10, 2023

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...

Breast Cancer

FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer

The ASCO Post Staff  /  February 25, 2023

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...

CNS Cancers

FDA Approves New, Updated Indications for Temozolomide

The ASCO Post Staff  /  October 25, 2023

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 ...

Breast Cancer

Recent FDA Approvals in Breast Cancer

The ASCO Post Staff  /  October 10, 2023 - Supplement: Breast Cancer Almanac

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...

Skin Cancer

FDA Approves Melphalan Hepatic Delivery System for Adult Patients With Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

The ASCO Post Staff  /  September 25, 2023

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...

Multiple Myeloma

Accelerated Approval for Elranatamab-bcmm in Patients With Relapsed or Refractory Multiple Myeloma

The ASCO Post Staff  /  September 10, 2023

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...

Hematologic Malignancies

Recent FDA Approvals in Hematologic Oncology

The ASCO Post Staff  /  August 10, 2023 - Supplement: Hematologic Oncology Almanac

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...

Hematologic Malignancies
Supportive Care

FDA Approves Omidubicel-onlv to Reduce Time to Neutrophil Recovery and Infection in Patients With Hematologic Malignancies

The ASCO Post Staff  /  May 10, 2023

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 ...

Breast Cancer
Immunotherapy

FDA Approves Sacituzumab Govitecan-hziy for Pretreated Patients With HR-Positive, HER2-Negative Breast Cancer

The ASCO Post Staff  /  February 25, 2023

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...

Lymphoma

FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

The ASCO Post Staff  /  February 25, 2023

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...

Gynecologic Cancers

FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

The ASCO Post Staff  /  December 10, 2022

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...

Hematologic Malignancies

FDA Approves Oral MEK Inhibitor Cobimetinib for Histiocytic Neoplasms

The ASCO Post Staff  /  December 10, 2022

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...

Lung Cancer
Immunotherapy

FDA Approves Cemiplimab-rwlc in Combination With Platinum-Based Chemotherapy for NSCLC

The ASCO Post Staff  /  December 10, 2022

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...

Hematologic Malignancies

FDA Grants Accelerated Approval to Teclistamab-cqyv for Resistant Myeloma

The ASCO Post Staff  /  November 25, 2022

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...

Hepatobiliary Cancer

FDA Grants Accelerated Approval to Futibatinib for Previously Treated Patients With FGFR2-Mutated Cholangiocarcinoma

The ASCO Post Staff  /  November 10, 2022

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...

Lung Cancer
Genomics/Genetics

FDA Approves Selpercatinib for Locally Advanced or Metastatic RET Fusion–Positive NSCLC

The ASCO Post Staff  /  November 10, 2022

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...

Leukemia
Lymphoma
Myelodysplastic Syndromes

FDA Approves Pemigatinib for Patients With Myeloid/Lymphoid Neoplasms and FGFR1 Rearrangement

The ASCO Post Staff  /  November 10, 2022

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...

Supportive Care
Symptom Management

FDA Approves Sodium Thiosulfate to Reduce the Risk of Ototoxicity Associated With Cisplatin

The ASCO Post Staff  /  October 25, 2022

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  /  October 10, 2022 - Supplement: Breast Cancer Almanac

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 ...

Symptom Management
Supportive Care

FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-vs-Host Disease

The ASCO Post Staff  /  September 25, 2022

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 ...

Hepatobiliary Cancer
Immunotherapy

FDA Approves Durvalumab-Based Combination for Locally Advanced or Metastatic Biliary Tract Cancer

The ASCO Post Staff  /  September 25, 2022

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...

Lung Cancer
Genomics/Genetics

FDA Approves Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutations

The ASCO Post Staff  /  September 10, 2022

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 ...

Prostate Cancer

FDA Approves Darolutamide for Metastatic Hormone-Sensitive Prostate Cancer

The ASCO Post Staff  /  September 10, 2022

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...

Solid Tumors

FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumors

The ASCO Post Staff  /  September 10, 2022

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...

Lung Cancer

FDA Grants Accelerated Approval to Trastuzumab Deruxtecan for HER2-Mutant NSCLC

The ASCO Post Staff  /  September 10, 2022

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...

Gynecologic Cancers

Companion Diagnostic to Identify Patients With Endometrial Cancer Eligible for Pembrolizumab Therapy Approved by the FDA

The ASCO Post Staff  /  September 10, 2022

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 ...

Thyroid Cancer

FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer

The ASCO Post Staff  /  August 25, 2022 - Supplement: Head & Neck Almanac

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...

Lymphoma
Immunotherapy

FDA Approves Lisocabtagene Maraleucel for the Second-Line Treatment of Large B-Cell Lymphoma

The ASCO Post Staff  /  July 25, 2022

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...

Solid Tumors
Genomics/Genetics

Dabrafenib/Trametinib Combination Receives FDA Approval for BRAF V600E–Mutated Solid Tumors

The ASCO Post Staff  /  July 10, 2022

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  /  July 10, 2022

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 ...

Leukemia

FDA Approves Ivosidenib/Azacitidine for Certain Patients With Newly Diagnosed AML

The ASCO Post Staff  /  June 10, 2022

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...

Leukemia

FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia

The ASCO Post Staff  /  June 10, 2022

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...

Gastroesophageal Cancer
Immunotherapy

FDA Approves Two Nivolumab-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

The ASCO Post Staff  /  June 10, 2022

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  /  June 3, 2022 - Narratives Special Issue

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...

Breast Cancer
Immunotherapy

FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Breast Cancer

The ASCO Post Staff  /  May 25, 2022

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...

Skin Cancer
Immunotherapy

FDA Approves Nivolumab/Relatlimab-rmbw for Unresectable or Metastatic Melanoma

The ASCO Post Staff  /  May 10, 2022

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 ...

Lymphoma
Immunotherapy

FDA Approves Axicabtagene Ciloleucel for the Second-Line Treatment of Large B-Cell Lymphoma

The ASCO Post Staff  /  April 25, 2022

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...

Prostate Cancer

FDA Approves Radioligand for Metastatic Castration-Resistant Prostate Cancer

The ASCO Post Staff  /  April 25, 2022

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...

Gynecologic Cancers
Immunotherapy

FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma

The ASCO Post Staff  /  April 10, 2022

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...

Breast Cancer

FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer

The ASCO Post Staff  /  April 10, 2022

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...

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