In the Clinic
Retifanlimab-dlwr for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma
Matthew Stenger
On March 22, 2023, the anti–PD-1 antibody retifanlimab-dlwr was granted accelerated approval for adults with metastatic or recurrent locally advanced Merkel cell carcinoma.1 Supporting Efficacy Data Approval was based on findings in POD1UM-201 (ClinicalTrials.gov identifier NCT03599713), a multice...
Omidubicel-onlv to Reduce Time to Neutrophil Recovery and Incidence of Infection in Hematologic Malignancies
Matthew Stenger
On April 17, 2023, omidubicel-onlv was approved for use in adult and pediatric patients (≥ 12 years) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.1 ...
Enfortumab Vedotin-ejfv With Pembrolizumab in Locally Advanced or Metastatic Urothelial Carcinoma
Matthew Stenger
On April 3, 2023, enfortumab vedotin-ejfv with pembrolizumab was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy.1,2 Enfortumab vedotin-ejfv is an antibody-drug conjugate targeting nectin 4. Suppo...
Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Matthew Stenger
On January 27, 2023, pirtobrutinib was granted accelerated approval for treatment of relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.1 Pirtobrutinib is a noncovalent inhibitor of BTK. Supporting Efficacy ...
Dabrafenib With Trametinib for Pediatric Low-Grade Glioma With BRAF V600E Mutation
Matthew Stenger
On March 16, 2023, dabrafenib with trametinib was approved for pediatric patients aged 1 year and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.1,2 The U.S. Food and Drug Administration also approved new oral formulations of both drugs suitable for patients who ...
Abemaciclib Expanded Indication for Adjuvant Use in HR-Positive, HER2-Negative, Node-Positive Early Breast Cancer
Matthew Stenger
On March 3, 2023, abemaciclib was approved for use with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with hormone receptor (HR)-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.1 Abemaciclib was previously approved in...
Regular Approval for Dostarlimab-gxly in dMMR Recurrent or Advanced Endometrial Cancer
Matthew Stenger
On February 9, 2023, dostarlimab-gxly was granted regular approval for adults with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a U.S. Food and Drug Administration–approved test, whose disease has progressed on or following a prior platinum-containing r...
Tucatinib With Trastuzumab in Previously Treated RAS Wild-Type HER2-Positive Advanced Colorectal Cancer
Matthew Stenger
On January 19, 2023, tucatinib was grated accelerated approval for use in combination with trastuzumab for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.1 Supporting Efficacy Dat...
Sacituzumab Govitecan-hziy in HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Matthew Stenger
On February 3, 2023, sacituzumab govitecan-hziy was approved for unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+/in situ hybridization–negative) breast cancer who have received endocrine-based therapy and at l...
Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
Matthew Stenger
On January 27, 2023, elacestrant was approved by the U.S. Food and Drug Administration (FDA) 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 ...
Zanubrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Matthew Stenger
On January 19, 2023, the kinase inhibitor zanubrutinib was approved for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1 Supporting Efficacy Data Approval was based on findings in the SEQUOIA trial (ClinicalTrials.gov identifier NCT03336333) in patients with tr...
Mosunetuzumab-axgb for Relapsed or Refractory Follicular Lymphoma
Matthew Stenger
On December 22, 2022, mosunetuzumab-axgb, a bispecific CD20-directed CD3 T-cell engager, was granted accelerated approval for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1 Supporting Efficacy Data Approval was based on findings in the multicen...
First Adenoviral Vector–Based Gene Therapy for High-Risk BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer
Matthew Stenger
On December 16, 2022, nadofaragene firadenovec-vncg, an adenoviral vector–based gene therapy, was approved for patients with high-risk bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.1 Supporting Efficacy Data A...
Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With a Susceptible IDH1 Mutation
Matthew Stenger
On December 1, 2022, the IDH1 inhibitor olutasidenib was approved for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Abbott RealT...
Tremelimumab-actl in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
Matthew Stenger
On October 21, 2022, tremelimu-mab-actl was approved by the U.S. Food and Drug Administration (FDA) for use in combination with durvalumab in the treatment of unresectable hepatocellular carcinoma.1 Supporting Efficacy Data Approval was based on a comparison of overall survival in the tremelimumab...
Mirvetuximab Soravtansine for FRɑ-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Matthew Stenger
On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted mirvetuximab soravtansine-gynx accelerated approval for patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three pri...
Sodium Thiosulfate to Reduce the Risk of Cisplatin-Related Ototoxicity in Pediatric Patients With Localized Solid Tumors
Matthew Stenger
On September 20, 2022, sodium thiosulfate was approved to reduce the risk of ototoxicity associated with cisplatin in pediatric patients (aged ≥ 1 month) with localized, nonmetastatic solid tumors.1 Supporting Efficacy Data Approval was based on findings in the multicenter open-label SIOPEL 6 (Cli...
Ivosidenib/Azacitidine for Newly Diagnosed IDH1-Mutant Acute Myeloid Leukemia in Patients Aged 75 or Older or With Comorbidities
Matthew Stenger
On May 25, 2022, ivosidenib was approved for use in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration–approved test, in patients aged 75 or older or in those who have comorbidities precluding t...
Tremelimumab Combined With Durvalumab and Platinum-Based Chemotherapy in Metastatic NSCLC
Matthew Stenger
On November 10, 2022, tremelimu-mab in combination with durvalumab and platinum-based chemotherapy was approved for patients with metastatic non–small cell lung cancer (NSCLC) with no sensitizing EGFR mutation or ALK genomic tumor aberrations.1 Supporting Efficacy Data Approval was supported by fi...
Brentuximab Vedotin Combined With Chemotherapy in Pediatric Classical Hodgkin Lymphoma
Matthew Stenger
On November 10, 2022, brentuximab vedotin was approved for use in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged ≥ 2 years with previously untreated high-risk classical Hodgkin lymphoma.1 Supporting Efficacy Data Approval was supp...
Cemiplimab/Chemotherapy Combination in Advanced NSCLC With No EGFR, ALK, or ROS1 Aberrations
Matthew Stenger
On November 8, 2022, cemiplimab-rwlc was approved for use in combination with platinum-based chemotherapy for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.1 Supporting Efficacy Data Approval was supported by findings in th...
Teclistamab in the Treatment of Relapsed or Refractory Multiple Myeloma
Matthew Stenger
On October 25, 2022, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager teclistamab-cqyv was granted accelerated approval for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome i...
Dabrafenib in Combination With Trametinib for Unresectable or Metastatic Solid Tumors With BRAF V600E Mutation
Matthew Stenger
On June 22, 2022, dabrafenib in combination with trametinib was granted accelerated approval for treatment of adult and pediatric patients (aged 6 and older) with unresectable or metastatic solid tumors with BRAF V600E mutation whose disease progressed following prior treatment and who have no satis...
Durvalumab Plus Chemotherapy in Advanced Biliary Tract Cancer
Matthew Stenger
On September 2, 2022, durvalumab was approved for use in combination with gemcitabine/cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on findings in the double-blind TOPAZ-1 trial (NCT03875235), in which...
Futibatinib for Cholangiocarcinoma With FGFR2 Gene Fusion or Other Rearrangements
Matthew Stenger
On September 30, 2022, futibatinib was granted accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.1 Supporting Efficacy Data...
Selpercatinib Approved for Advanced RET Fusion–Positive Solid Tumors and Advanced RET Fusion–Positive NSCLC
Matthew Stenger
On September 21, 2022, selpercatinib was granted accelerated approval for adults with locally advanced or metastatic solid tumors with RET gene fusion whose disease has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.1 On the same day, se...
Trastuzumab Deruxtecan for Advanced HER2-Low Breast Cancer
Matthew Stenger
On August 5, 2022, fam-trastuzumab deruxte-can-nxki was approved for patients with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization–negative) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence...
Lutetium Lu-177 Vipivotide Tetraxetan for PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On March 23, 2022, the radioligand therapeutic agent lutetium Lu-177 vipivotide tetraxetan was approved for treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with an androgen receptor pathway inhibitor ...
Ibrutinib for Pediatric Patients With Chronic Graft-vs-Host Disease
Matthew Stenger
On August 24, 2022, ibrutinib was approved for pediatric patients 1 year of age or older with chronic graft-vs-host disease after failure of one or more lines of systemic therapy.1 A new oral suspension formulation is available. Supporting Efficacy Data Approval was based on findings from the mult...
Darolutamide Combined With Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Matthew Stenger
On August 5, 2022, darolutamide was approved for use in combination with docetaxel for patients with metastatic hormone-sensitive prostate cancer.1 Approval was based on the double-blind ARASENS trial (ClinicalTrials.gov identifier NCT02799602), in which 1,305 patients were randomly assigned to rec...
Trastuzumab Deruxtecan for Advanced HER2-Mutant NSCLC
Matthew Stenger
On August 11, 2022, fam-trastuzumab deruxtecan-nxki was granted accelerated approval for unresectable or metastatic non–small cell lung cancer (NSCLC) with tumors that have activating HER2 mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test and who have received a prior...
Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation
Matthew Stenger
On August 10, 2022, capmatinib was granted regular approval for patients with metastatic non–small cell lung cancer (NSCLC) with tumors having a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by a U.S. Food and Drug Administration–approved test.1 Capmatinib...
Tisagenlecleucel for Relapsed or Refractory Follicular Lymphoma
Matthew Stenger
On May 27, 2022, tisagenlecleucel, a CD19 chimeric antigen receptor (CAR) T-cell therapy, was granted accelerated approval for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1 Supporting Efficacy Data Approval was based on the multicenter ELARA t...
Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia
Matthew Stenger
On May 20, 2022, azacitidine for injection was approved by the U.S. Food and Drug Administration for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia.1 Supporting Efficacy Data Approval was based on findings in the multicenter AZA-JMML-001 trial (ClinicalTrials.gov identifi...
Lisocabtagene Maraleucel in Second-Line Treatment of Large B-Cell Lymphoma
Matthew Stenger
On June 24, 2022, lisocabtagene maraleucel was approved for adults with large B-cell lymphoma (LBCL) who have (1) refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or (2) refractory disease to first-line chemoimmunotherapy or relapse af...
Crizotinib in Adult and Pediatric ALK-Positive Inflammatory Myofibroblastic Tumors
Matthew Stenger
On July 14, 2022, crizotinib was approved for adult and pediatric patients aged ≥ 1 year with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumors.1 Supporting Efficacy Data Approval was based on findings in the multicenter studies ADVL0912 (ClinicalTrials.gov id...
Nivolumab in Combination With Chemotherapy and in Combination With Ipilimumab in Advanced Esophageal Squamous Cell Carcinoma
Matthew Stenger
On May 27, 2022, nivolumab was approved for use in combination with fluoropyrimidine- and platinum-based chemotherapy and in combination with ipilimumab for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma.1 Supporting Efficacy Data Approval was based on findin...
Use of T-DXd in Previously Treated Patients With Advanced HER2-Positive Breast Cancer
Matthew Stenger
On May 4, 2022, fam-trastuzumab deruxtecan-nxki (T-DXd) was granted regular approval for patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2–based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disea...
Pembrolizumab for MSI-H/dMMR Advanced Endometrial Carcinoma
Matthew Stenger
On March 21, 2022, pembrolizumab was approved for patients with advanced endometrial carcinoma that is microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR), as determined by a U.S. Food and Drug Administration (FDA)-approved test, who have disease progression following prior s...
Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma
Matthew Stenger
On April 1, 2022, axicabtagene ciloleucel was approved for adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.1 It is not indicated for the treatment of patients with primary central nervous system lymph...
Neoadjuvant Nivolumab and Platinum-Doublet Chemotherapy for Early NSCLC
Matthew Stenger
On March 4, 2022, nivolumab was approved for use with platinum-doublet chemotherapy for resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting.1 The approval is the first for neoadjuvant therapy for early-stage NSCLC. Supporting Efficacy Data Approval was based on findings from t...
Ciltacabtagene Autoleucel in Relapsed or Refractory Multiple Myeloma
Matthew Stenger
On February 28, 2022, ciltacabtagene autoleucel was approved for treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1 Ciltacabtagene autoleucel is a ...
Fixed-Dose Nivolumab and Relatlimab-rmbw for Unresectable or Metastatic Melanoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On March 18, 2022, fixed-dose nivolumab and relatlimab-rm...
Tebentafusp-tebn for Unresectable or Metastatic Uveal Melanoma
Matthew Stenger
On January 25, 2022, tebentafusp-tebn, a bispecific gp100 peptide-HLA–directed CD3 T-cell engager, was approved for treatment of adults with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma.1 Supporting Efficacy Data Approval was based on findings in the open-label, multicenter IMCg...
Abatacept for Prophylaxis of Acute Graft-vs-Host Disease
Matthew Stenger
On December 15, 2021, abatacept, a selective T-cell costimulation modulator, was approved for prophylaxis of acute graft-vs-host disease in combination with a calcineurin inhibitor (eg, cyclosporine, tacrolimus) and methotrexate in adults and pediatric patients aged ≥ 2 years undergoing hematopoieti...
Daratumumab/Hyaluronidase-fihj and Carfilzomib in Multiple Myeloma
Matthew Stenger
On November 30, 2021, daratumumab/hyaluronidase-fihj and carfilzomib were approved for use in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who had one to three prior lines of therapy.1,2 Supporting Efficacy Data Approval was based on findings in a cohort ...
Rituximab Plus Chemotherapy for Pediatric Mature B-Cell Non-Hodgkin Lymphoma and Mature B-Cell Acute Leukemia
Matthew Stenger
On December 2, 2021, rituximab was approved for use in combination with chemotherapy for pediatric patients (≥ 6 months to 18 years) with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.1 Sup...
Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor
Matthew Stenger
On November 22, 2021, sirolimus protein-bound particles for injectable suspension (albumin-bound) was approved for treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.1 Supporting Efficacy Data Approval was supported by findings in the...
Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL
Matthew Stenger
On October 1, 2021, the CD19-directed chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel was approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 The product is available only through a restricted program under a Risk Evaluation...
Abemaciclib With Endocrine Therapy in Adjuvant Treatment of Early Breast Cancer
Matthew Stenger
On October 12, 2021, abemaciclib was approved for use with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adults with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki67 score ≥ 20%, as determined by an...
