In the Clinic
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 mu...
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 supported...
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 Effic...
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...
Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma
Matthew Stenger
On March 10, 2021, the VEGF tyrosine kinase inhibitor tivozanib was approved for treatment of adults with relapsed or refractory advanced renal cell carcinoma following at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on findings in the open-label, phase III TI...
Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Endometrial Cancer
Matthew Stenger
On April 22, 2021, the PD-1 inhibitor dostarlimab-gxly was granted accelerated approval for treatment of adults with mismatch repair–deficient recurrent or advanced endometrial cancer, as determined by a U.S. Food and Drug Administration (FDA)-approved test, that has progressed on or following a pri...
Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma
Matthew Stenger
On March 5, 2021, the CD19-directed genetically modified autologous T-cell immunotherapy axicabtagene ciloleucel was granted accelerated approval for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1,2 Axicabtagene ciloleucel is availa...
Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphoma
Matthew Stenger
On February 5, 2021, lisocabtagene maraleucel was approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent...
Avapritinib for Advanced Systemic Mastocytosis
Matthew Stenger
On June 16, 2021, avapritinib was approved for the treatment of adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.1,2 Avapritinib is not recommended for...
Loncastuximab Tesirine-lpyl for Relapsed or Refractory Large B-Cell Lymphoma
Matthew Stenger
On April 23, 2021, loncastuximab tesirine-lpyl, a CD19-directed antibody and alkylating agent conjugate, was granted accelerated approval for treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymp...
Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
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 February 26, 2021, the peptide-conjugated alkylating d...
Fam-trastuzumab Deruxtecan-nxki for Trastuzumab-Pretreated Advanced HER2-Positive Gastric Adenocarcinoma
Matthew Stenger
On January 15, 2021, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki was approved for treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.1,2 Supporting Efficacy Data Approv...
Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma
Matthew Stenger
On March 26, 2021, idecabtagene vicleucel was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.1,2 Idecabtagene vicleucel is t...
Cemiplimab-rwlc for First-Line Treatment of NSCLC With High PD-L1 Expression
Matthew Stenger
On February 22, 2021, cemiplimab-rwlc was approved for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC; locally advanced who are not candidates for surgical resection or definitive chemoradiation therapy or metastatic) whose tumors have high PD-L1 expression (tumor p...
Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
Matthew Stenger
On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for trea...
Umbralisib for Previously Treated Relapsed or Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Matthew Stenger
On February 5, 2021, umbralisib was granted accelerated approval for the following indications: adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti–CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have r...
Nivolumab Plus Cabozantinib as First-Line Treatment of Advanced Renal Cell Carcinoma
Matthew Stenger
On January 22, 2021, the U.S. Food and Drug Administration approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma.1-3 Supporting Efficacy Data Approval was based on the findings of the phase III, open-label CheckMate 9ER trial...
Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations
Matthew Stenger
On February 3, 2021, tepotinib was granted accelerated approval for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.1,2 Supporting Efficacy Data Approval was supported by findings from the...
Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive Anaplastic Large Cell Lymphoma
Matthew Stenger
On January 14, 2021, crizotinib was approved for treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.1,2 The safety and efficacy of crizotinib have not been established in older adult...
Pembrolizumab for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer
Matthew Stenger
On January 8, 2020, pembrolizumab was approved for treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1,2 Suppo...
Osimertinib in Adjuvant Therapy for NSCLC With EGFR Mutations
Matthew Stenger
On December 18, 2020, osimertinib was approved for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) with tumors with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Supporting Eff...
Margetuximab-cmkb for Previously Treated Metastatic HER2-Positive Breast Cancer
Matthew Stenger
On December 16, 2020, margetuximab-cmkb (margetuximab) was approved for use in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.1,2 S...
Selinexor in Relapsed or Refractory Multiple Myeloma
Matthew Stenger
On December 18, 2020, selinexor was approved for use in combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma who have received at least one prior therapy.1,2 Selinexor received accelerated approval in 2019 for use in combination with dexamethasone for ...
Relugolix for Advanced Prostate Cancer
Matthew Stenger
On December 18, 2020, relugolix was approved for the treatment of adult patients with advanced prostate cancer. Relugolix is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist to be approved in this setting.1,2 Supporting Efficacy Data Approval was based on findings in the op...
Pralsetinib for RET-Altered Thyroid Cancers
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 December 1, 2020, pralsetinib (Gavreto) was granted ap...
Pembrolizumab Plus Chemotherapy for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer
Matthew Stenger
On November 13, 2020, pembrolizumab (Keytruda) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer with tumors expressing PD-L1 (Combined ...
Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow
Matthew Stenger
On November 25, 2020, naxitamab-gqgk (Danyelza) was granted accelerated approval for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or...
Venetoclax in Combination Therapy for Untreated Acute Myeloid Leukemia
Matthew Stenger
On October 16, 2020, venetoclax was granted regular approval for use in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or those with comorbidities precluding intensive induction chemo...
