In the Clinic
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...
Asciminib for Philadelphia Chromosome–Positive Chronic Myeloid Leukemia
Matthew Stenger
On October 29, 2021, the oral kinase inhibitor asciminib was granted accelerated approval for adults with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase previously treated with at least two tyrosine kinase inhibitors and regular approval for adults with Philadelphia...
Atezolizumab in Adjuvant Therapy for PD-L1–Positive NSCLC
Matthew Stenger
On October 15, 2021, atezolizumab was approved for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells, as determined by a U.S. Food and Drug Administration (FDA)-appr...
Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
Matthew Stenger
On November 17, 2021, the immunotherapeutic agent pembrolizumab was granted approval for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.1 Supporting Efficacy Data Appr...
Pembrolizumab Plus Chemotherapy With or Without Bevacizumab in First-Line Treatment of Advanced Cervical Cancer
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 October 13, 2021, pembrolizumab in combination with ch...
Zanubrutinib for Relapsed or Refractory Marginal Zone Lymphoma
Matthew Stenger
On September 14, 2021, the Bruton’s tyrosine kinase inhibitor zanubrutinib was granted accelerated approval for adults with relapsed or refractory marginal zone lymphoma (MZL) who have had at least one prior anti-CD20–based regimen.1 Supporting Efficacy Data Approval was based on findings in the ...
Mobocertinib for Previously Treated Advanced NSCLC With EGFR Exon 20 Insertion Mutations
Matthew Stenger
On September 15, 2021, the kinase inhibitor mobocertinib was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose...
Ruxolitinib for Chronic Graft-vs-Host Disease After Failure of Systemic Therapy
Matthew Stenger
On September 22, 2021, ruxolitinib, a tyrosine kinase inhibitor of JAK1 and JAK2 was granted approval for treatment of chronic graft-vs-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients aged ≥ 12 years.1 Supporting Efficacy Data Approval was support...
Cabozantinib for Previously Treated Advanced Differentiated Thyroid Cancer
Matthew Stenger
On September 17, 2021, cabozantinib was approved for adult and pediatric patients aged ≥ 12 years with locally advanced or metastatic differentiated thyroid cancer progressing after VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.1 Cabozantinib inhibits the activit...
Tisotumab Vedotin-tftv in Recurrent or Metastatic Cervical Cancer
Matthew Stenger
On September 20, 2021, tisotumab vedotin-tftv, a tissue factor-directed antibody and microtubule inhibitor conjugate, was granted accelerated approval for the treatment of adults with recurrent or metastatic cervical cancer who have had disease progression on or after chemotherapy.1 Supporting Effi...
Zanubrutinib for Waldenström’s Macroglobulinemia
Matthew Stenger
On August 31, 2021, the Bruton’s tyrosine kinase inhibitor zanubrutinib was approved for treatment of adults with Waldenström’s macroglobulinemia.1 Supporting Efficacy Data Approval was based on findings in patients receiving zanubrutinib in the phase III open-label ASPEN trial (ClinicalTrials.gov...
Ivosidenib for Previously Treated IDH1-Mutant Advanced or Metastatic Cholangiocarcinoma
Matthew Stenger
On August 25, 2021, ivosidenib was approved for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Oncomine Dx Target Test as a companion...
Pembrolizumab and Lenvatinib in Advanced Endometrial Carcinoma
Matthew Stenger
On July 21, 2021, pembrolizumab in combination with lenvatinib was granted regular approval for treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair–deficient who have disease progression following prior systemic therapy in any sett...
Nivolumab for Adjuvant Treatment of Urothelial Carcinoma
Matthew Stenger
On August 19, 2021, the PD-1 inhibitor nivolumab was approved for adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection.1 This is the first approval by the U.S. Food and Drug Administration for adjuvant treatment of patients w...
Lenvatinib Plus Pembrolizumab for First-Line Treatment of Advanced Renal Cell Carcinoma
Matthew Stenger
On August 10, 2021, the combination of lenvatinib plus pembrolizumab was approved for first-line treatment of adults with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings from the three-arm, open-label, phase III CLEAR trial (Study 307/KEYNOTE-581; Clinical...
Belzutifan for Cancers Associated With von Hippel-Lindau Disease
Matthew Stenger
On August 13, 2021, belzutifan, a hypoxia-inducible factor inhibitor, was approved for treatment of adults with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma, central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors but do not requ...
Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Solid Tumors
Matthew Stenger
On August 17, 2021, dostarlimab-gxly, aPD-1 blocking monoclonal antibody, was granted accelerated approval for adults with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by a U.S. Food and Drug Administration (FDA)-approved test, who have had disease progression a...
Daratumumab and Hyaluronidase-fihj With Pomalidomide Plus Dexamethasone in Multiple Myeloma
Matthew Stenger
On July 9, 2021, daratumumab and hyaluronidase-fihj was approved for use in combination with pomalidomide and dexamethasone (Pd) for treatment of adults with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.1 Supporting Efficac...
Amivantamab-vmjw for Previously Treated Advanced NSCLC With EGFR Mutation
Matthew Stenger
On May 21, 2021, amivantamab-vmjw, a bispecific antibody directed against EGFR and MET receptors, was granted accelerated approval for treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by a U.S. Food and Drug...
Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Matthew Stenger
On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal juncti...
Enfortumab Vedotin-ejfv in Urothelial Cancer
Matthew Stenger
On July 9, 2021, enfortumab vedotin-ejfv, an antibody-drug conjugate targeting nectin-4, was granted regular approval. The agent is indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and platinum chemotherapy or are...
Pembrolizumab for High-Risk, Early-Stage Triple-Negative Breast Cancer
Matthew Stenger
On July 26, 2021, pembrolizumab was approved for high-risk, early-stage, triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and continued as adjuvant treatment.1 Pembrolizumab was also granted regular approval in combination with chemotherapy for locally recurre...
Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Triple-Negative Breast Cancer
Matthew Stenger
On April 7, 2021, sacituzumab govitecan-hziy was granted regular approval for treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.1 Sacituzumab govite...
Belumosudil for Chronic Graft-vs-Host Disease
Matthew Stenger
On July 16, 2021, belumosudil, an inhibitor of Rho-associated coiled-coil kinase 2, was approved for the treatment of adult and pediatric patients 12 years and older with chronic graft-vs-host disease after the failure of at least two prior lines of systemic therapy.1 Supporting Efficacy Data Appr...
Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Urothelial Cancer
Matthew Stenger
On April 13, 2021, sacituzumab govitecan-hziy was granted accelerated approval to treat patients with locally advanced or metastatic urothelial cancer who had received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor.1 Supporting Efficacy Data Approval was based on findings ...
Isatuximab-irfc in Relapsed or Refractory Multiple Myeloma
Matthew Stenger
On March 31, 2021, the anti-CD38 monoclonal antibody isatuximab-irfc was approved for use in combination with carfilzomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.1 Supporting Efficacy Data Appr...
Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Matthew Stenger
On June 30, 2021, asparaginase erwinia chrysanthemi (recombinant)-rywn was approved as a component of a multiagent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitiv...
Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression in Extensive-Stage Small Cell Lung Cancer
Matthew Stenger
On February 12, 2021, the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor trilaciclib was approved for use to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide–containing regimen or topotecan-containing regimen for extens...
Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer
Matthew Stenger
On May 20, 2021, nivolumab was approved for adjuvant treatment of patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease after neoadjuvant chemoradiotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the double-...
Lorlatinib for Metastatic ALK-Positive NSCLC
Matthew Stenger
On March 3, 2021, lorlatinib was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) with ALK-positive tumors as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA simultaneously approved the Ventana ALK (D5F3) CDx Assay ...
Pembrolizumab Combined With Chemotherapy for Advanced Esophageal or Gastroesophageal Junction Carcinoma
Matthew Stenger
On March 22, 2021, pembrolizumab was approved for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1 to 5 cm above the gastroesophageal junction) carcinoma who are...
