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In the Clinic

Lymphoma

Zanubrutinib for Relapsed or Refractory Marginal Zone Lymphoma

Matthew Stenger  /  October 25, 2021

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...

Lung Cancer
Genomics/Genetics

Mobocertinib for Previously Treated Advanced NSCLC With EGFR Exon 20 Insertion Mutations

Matthew Stenger  /  October 25, 2021

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...

Symptom Management

Ruxolitinib for Chronic Graft-vs-Host Disease After Failure of Systemic Therapy

Matthew Stenger  /  October 25, 2021

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...

Thyroid Cancer

Cabozantinib for Previously Treated Advanced Differentiated Thyroid Cancer

Matthew Stenger  /  October 25, 2021

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...

Gynecologic Cancers

Tisotumab Vedotin-tftv in Recurrent or Metastatic Cervical Cancer

Matthew Stenger  /  October 25, 2021

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...

Hematologic Malignancies

Zanubrutinib for Waldenström’s Macroglobulinemia

Matthew Stenger  /  October 10, 2021

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...

Hepatobiliary Cancer

Ivosidenib for Previously Treated IDH1-Mutant Advanced or Metastatic Cholangiocarcinoma

Matthew Stenger  /  September 25, 2021

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...

Gynecologic Cancers
Immunotherapy

Pembrolizumab and Lenvatinib in Advanced Endometrial Carcinoma

Matthew Stenger  /  September 25, 2021

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...

Bladder Cancer
Immunotherapy

Nivolumab for Adjuvant Treatment of Urothelial Carcinoma

Matthew Stenger  /  September 25, 2021

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...

Kidney Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab for First-Line Treatment of Advanced Renal Cell Carcinoma

Matthew Stenger  /  September 25, 2021

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...

Solid Tumors

Belzutifan for Cancers Associated With von Hippel-Lindau Disease

Matthew Stenger  /  September 25, 2021

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...

Immunotherapy
Solid Tumors

Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Solid Tumors

Matthew Stenger  /  September 25, 2021

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...

Multiple Myeloma

Daratumumab and Hyaluronidase-fihj With Pomalidomide Plus Dexamethasone in Multiple Myeloma

Matthew Stenger  /  September 10, 2021

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...

Lung Cancer

Amivantamab-vmjw for Previously Treated Advanced NSCLC With EGFR Mutation

Matthew Stenger  /  September 10, 2021

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...

Immunotherapy
Gastroesophageal Cancer

Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Matthew Stenger  /  September 10, 2021

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...

Bladder Cancer

Enfortumab Vedotin-ejfv in Urothelial Cancer

Matthew Stenger  /  September 10, 2021

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...

Breast Cancer
Immunotherapy

Pembrolizumab for High-Risk, Early-Stage Triple-Negative Breast Cancer

Matthew Stenger  /  September 10, 2021

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...

Breast Cancer
Immunotherapy

Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Triple-Negative Breast Cancer

Matthew Stenger  /  August 25, 2021

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...

Hematologic Malignancies
Symptom Management

Belumosudil for Chronic Graft-vs-Host Disease

Matthew Stenger  /  August 25, 2021

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...

Bladder Cancer
Immunotherapy

Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Urothelial Cancer

Matthew Stenger  /  August 25, 2021

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 ...

Multiple Myeloma

Isatuximab-irfc in Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  August 25, 2021

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...

Leukemia
Lymphoma

Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Matthew Stenger  /  August 10, 2021

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...

Lung Cancer

Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression in Extensive-Stage Small Cell Lung Cancer

Matthew Stenger  /  August 10, 2021

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...

Head and Neck Cancer
Immunotherapy

Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer

Matthew Stenger  /  August 10, 2021

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-...

Lung Cancer

Lorlatinib for Metastatic ALK-Positive NSCLC

Matthew Stenger  /  July 25, 2021

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 ...

Solid Tumors
Gastroesophageal Cancer

Pembrolizumab Combined With Chemotherapy for Advanced Esophageal or Gastroesophageal Junction Carcinoma

Matthew Stenger  /  July 25, 2021

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...

Kidney Cancer

Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma

Matthew Stenger  /  July 25, 2021

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...

Gynecologic Cancers
Immunotherapy

Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Endometrial Cancer

Matthew Stenger  /  July 25, 2021

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...

Lymphoma
Immunotherapy

Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma

Matthew Stenger  /  July 25, 2021

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...

Lymphoma
Immunotherapy

Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphoma

Matthew Stenger  /  July 25, 2021

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...

Hematologic Malignancies

Avapritinib for Advanced Systemic Mastocytosis

Matthew Stenger  /  July 25, 2021

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...

Lymphoma
Immunotherapy

Loncastuximab Tesirine-lpyl for Relapsed or Refractory Large B-Cell Lymphoma

Matthew Stenger  /  July 25, 2021

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...

Multiple Myeloma

Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  May 25, 2021

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...

Gastrointestinal Cancer
Immunotherapy

Fam-trastuzumab Deruxtecan-nxki for Trastuzumab-Pretreated Advanced HER2-Positive Gastric Adenocarcinoma

Matthew Stenger  /  May 25, 2021

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...

Multiple Myeloma
Immunotherapy

Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  May 25, 2021

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...

Lung Cancer
Immunotherapy

Cemiplimab-rwlc for First-Line Treatment of NSCLC With High PD-L1 Expression

Matthew Stenger  /  May 10, 2021

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...

Skin Cancer
Immunotherapy

Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma

Matthew Stenger  /  April 25, 2021

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...

Lymphoma

Umbralisib for Previously Treated Relapsed or Refractory Marginal Zone Lymphoma and Follicular Lymphoma

Matthew Stenger  /  April 25, 2021

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...

Kidney Cancer
Immunotherapy

Nivolumab Plus Cabozantinib as First-Line Treatment of Advanced Renal Cell Carcinoma

Matthew Stenger  /  March 25, 2021

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...

Lung Cancer

Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations

Matthew Stenger  /  March 10, 2021

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...

Lymphoma

Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive Anaplastic Large Cell Lymphoma

Matthew Stenger  /  March 10, 2021

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...

Immunotherapy
Bladder Cancer

Pembrolizumab for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer

Matthew Stenger  /  February 25, 2020

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...

Lung Cancer

Osimertinib in Adjuvant Therapy for NSCLC With EGFR Mutations

Matthew Stenger  /  January 25, 2021

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...

Breast Cancer

Margetuximab-cmkb for Previously Treated Metastatic HER2-Positive Breast Cancer

Matthew Stenger  /  January 25, 2021

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...

Multiple Myeloma

Selinexor in Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  January 25, 2021

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 ...

Prostate Cancer

Relugolix for Advanced Prostate Cancer

Matthew Stenger  /  January 25, 2021

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...

Head and Neck Cancer

Pralsetinib for RET-Altered Thyroid Cancers

Matthew Stenger  /  December 25, 2020

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...

Breast Cancer

Pembrolizumab Plus Chemotherapy for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer

Matthew Stenger  /  December 25, 2020

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 ...

Solid Tumors
Immunotherapy

Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow

Matthew Stenger  /  December 25, 2020

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...

Leukemia

Venetoclax in Combination Therapy for Untreated Acute Myeloid Leukemia

Matthew Stenger  /  November 25, 2020

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...

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