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In the Clinic

Leukemia

Bosutinib in Pediatric Chronic Myeloid Leukemia

Matthew Stenger  /  November 25, 2023

On September 26, 2023, bosutinib (Bosulif) was approved for pediatric patients aged 1 year and older with chronic-phase Philadelphia chromosome–positive chronic myeloid leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy.1 New capsule dosage form strengths of 50 mg and...

Skin Cancer

Melphalan-Based Liver-Directed Therapy for Metastatic Uveal Melanoma

Matthew Stenger  /  October 10, 2023

On August 14, 2023, the Hepzato Kit—melphalan for injection/hepatic delivery system—was approved as a liver-directed treatment for adults with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver.1 Patients must have either no extrahepatic disease or extrahepatic ...

Multiple Myeloma

Accelerated Approval Granted for Use of Elranatamab-bcmm in Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  October 10, 2023

On August 14, 2023, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager elranatamab-bcmm was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of ther...

Multiple Myeloma

Accelerated Approval Granted for Talquetamab-tgvs in Treatment of Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  September 25, 2023

On August 9, 2023, the bispecific GPRC5D (G protein–coupled receptor, class C, group 5)-directed CD3 T-cell engager talquetamab-tgvs was granted accelerated approval by the U.S. Food and Drug Administration for treatment of adults with relapsed or refractory multiple myeloma who have received at lea...

Prostate Cancer

Fixed-Dose Niraparib and Abiraterone Plus Prednisone in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  September 25, 2023

On August 11, 2023, the fixed-dose combination of the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate plus prednisone was approved for patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer, as determined by a U.S. Food and Drug Admi...

Leukemia

Quizartinib in Newly Diagnosed FLT3-ITD–Positive Acute Myeloid Leukemia

Matthew Stenger  /  September 10, 2023

On July 20, 2023, quizartinib was approved for use with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy in adults with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication (ITD...

Colorectal Cancer

Trifluridine/Tipiracil Plus Bevacizumab in Previously Treated Metastatic Colorectal Cancer

Matthew Stenger  /  September 10, 2023

On August 2, 2023, the fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, was approved for use with bevacizumab for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemoth...

Gynecologic Cancers

Dostarlimab-gxly With Chemotherapy for Endometrial Cancer

Matthew Stenger  /  September 10, 2023

On July 31, 2023, the immune checkpoint inhibitor dostarlimab-gxly was approved by the U.S. Food and Drug Administration (FDA) for use with carboplatin and paclitaxel, followed by single-agent dostarlimab, for patients with primary advanced or recurrent endometrial cancer that is mismatch repair–def...

Prostate Cancer

Talazoparib With Enzalutamide in HRR Gene–Mutated Metastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  August 10, 2023

On June 20, 2023, the PARP inhibitor talazoparib was approved for use with enzalutamide in homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer.1 Supporting Efficacy Data Approval was based on findings in the multicohort, double-blind TALAPRO-2 trial (...

Lymphoma

Glofitamab-gxbm for Select Relapsed or Refractory Large B-Cell Lymphomas

Matthew Stenger  /  July 25, 2023

On June 15, 2023, the bispecific CD20-directed CD3 T-cell engager glofitamab-gxbm was granted accelerated approval for relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma after at least two lines of sys...

Prostate Cancer

Olaparib With Abiraterone and Prednisone or Prednisolone for BRCA-Mutated, Metastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  July 10, 2023

On May 31, 2023, the PARP inhibitor olaparib was approved by the U.S. Food and Drug Administration (FDA) with abiraterone and prednisone or prednisolone for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.1 Ap...

Lymphoma
Immunotherapy

Epcoritamab-bysp in Treatment of Relapsed or Refractory B-Cell Lymphomas

Matthew Stenger  /  July 10, 2023

On May 19, 2023, epcoritamab-bysp was granted accelerated approval by the U.S. Food and Drug Administration for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two ...

Hematologic Malignancies

Polatuzumab Vedotin-piiq for Previously Untreated DLBCL–Not Otherwise Specified and High-Grade B-Cell Lymphoma

Matthew Stenger  /  June 10, 2023

On April 19, 2023, polatuzumab vedotin-piiq was approved for use with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for patients with diffuse large B-cell lymphoma (DLBCL)–not otherwise specified or those with high-grade B-cell lymphoma who have an International Prognost...

Skin Cancer

Retifanlimab-dlwr for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma

Matthew Stenger  /  May 25, 2023

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...

Hematologic Malignancies

Omidubicel-onlv to Reduce Time to Neutrophil Recovery and Incidence of Infection in Hematologic Malignancies

Matthew Stenger  /  May 25, 2023

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 ...

Bladder Cancer
Immunotherapy

Enfortumab Vedotin-ejfv With Pembrolizumab in Locally Advanced or Metastatic Urothelial Carcinoma

Matthew Stenger  /  May 10, 2023

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...

Lymphoma

Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Matthew Stenger  /  March 25, 2023

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 ...

Head and Neck Cancer

Dabrafenib With Trametinib for Pediatric Low-Grade Glioma With BRAF V600E Mutation

Matthew Stenger  /  April 25, 2023

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 ...

Breast Cancer

Abemaciclib Expanded Indication for Adjuvant Use in HR-Positive, HER2-Negative, Node-Positive Early Breast Cancer

Matthew Stenger  /  April 10, 2023

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...

Gynecologic Cancers
Immunotherapy

Regular Approval for Dostarlimab-gxly in dMMR Recurrent or Advanced Endometrial Cancer

Matthew Stenger  /  March 25, 2023

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...

Colorectal Cancer

Tucatinib With Trastuzumab in Previously Treated RAS Wild-Type HER2-Positive Advanced Colorectal Cancer

Matthew Stenger  /  March 10, 2023

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...

Breast Cancer

Sacituzumab Govitecan-hziy in HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Matthew Stenger  /  March 10, 2023

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...

Breast Cancer

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

Matthew Stenger  /  March 10, 2023

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 ...

Leukemia
Lymphoma

Zanubrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Matthew Stenger  /  February 25, 2023

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...

Lymphoma

Mosunetuzumab-axgb for Relapsed or Refractory Follicular Lymphoma

Matthew Stenger  /  February 10, 2023

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...

Bladder Cancer

First Adenoviral Vector–Based Gene Therapy for High-Risk BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer

Matthew Stenger  /  January 25, 2023

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...

Leukemia

Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With a Susceptible IDH1 Mutation

Matthew Stenger  /  January 25, 2023

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...

Hepatobiliary Cancer
Immunotherapy

Tremelimumab-actl in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma

Matthew Stenger  /  January 25, 2023

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...

Gynecologic Cancers

Mirvetuximab Soravtansine for FRɑ-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Matthew Stenger  /  December 25, 2022

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...

Supportive Care

Sodium Thiosulfate to Reduce the Risk of Cisplatin-Related Ototoxicity in Pediatric Patients With Localized Solid Tumors

Matthew Stenger  /  December 25, 2022

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...

Leukemia

Ivosidenib/Azacitidine for Newly Diagnosed IDH1-Mutant Acute Myeloid Leukemia in Patients Aged 75 or Older or With Comorbidities

Matthew Stenger  /  December 25, 2022

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...

Lung Cancer

Tremelimumab Combined With Durvalumab and Platinum-Based Chemotherapy in Metastatic NSCLC

Matthew Stenger  /  December 25, 2022

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...

Lymphoma

Brentuximab Vedotin Combined With Chemotherapy in Pediatric Classical Hodgkin Lymphoma

Matthew Stenger  /  December 25, 2022

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...

Immunotherapy

Cemiplimab/Chemotherapy Combination in Advanced NSCLC With No EGFR, ALK, or ROS1 Aberrations

Matthew Stenger  /  December 10, 2022

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...

Multiple Myeloma

Teclistamab in the Treatment of Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  December 10, 2022

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...

Solid Tumors

Dabrafenib in Combination With Trametinib for Unresectable or Metastatic Solid Tumors With BRAF V600E Mutation

Matthew Stenger  /  December 10, 2022

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...

Immunotherapy

Durvalumab Plus Chemotherapy in Advanced Biliary Tract Cancer

Matthew Stenger  /  December 10, 2022

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...

Solid Tumors

Futibatinib for Cholangiocarcinoma With FGFR2 Gene Fusion or Other Rearrangements

Matthew Stenger  /  December 10, 2022

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...

Lung Cancer

Selpercatinib Approved for Advanced RET Fusion–Positive Solid Tumors and Advanced RET Fusion–Positive NSCLC

Matthew Stenger  /  December 10, 2022

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...

Breast Cancer

Trastuzumab Deruxtecan for Advanced HER2-Low Breast Cancer

Matthew Stenger  /  November 25, 2022

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...

Prostate Cancer

Lutetium Lu-177 Vipivotide Tetraxetan for PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  November 10, 2022

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 ...

Symptom Management

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

Matthew Stenger  /  October 10, 2022

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...

Prostate Cancer

Darolutamide Combined With Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Matthew Stenger  /  October 10, 2022

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...

Lung Cancer

Trastuzumab Deruxtecan for Advanced HER2-Mutant NSCLC

Matthew Stenger  /  September 25, 2022

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...

Lung Cancer

Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation

Matthew Stenger  /  September 25, 2022

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...

Lymphoma

Tisagenlecleucel for Relapsed or Refractory Follicular Lymphoma

Matthew Stenger  /  August 25, 2022

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...

Leukemia

Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia

Matthew Stenger  /  August 25, 2022

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...

Lymphoma

Lisocabtagene Maraleucel in Second-Line Treatment of Large B-Cell Lymphoma

Matthew Stenger  /  August 25, 2022

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...

Solid Tumors

Crizotinib in Adult and Pediatric ALK-Positive Inflammatory Myofibroblastic Tumors

Matthew Stenger  /  August 25, 2022

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...

Gastroesophageal Cancer

Nivolumab in Combination With Chemotherapy and in Combination With Ipilimumab in Advanced Esophageal Squamous Cell Carcinoma

Matthew Stenger  /  June 25, 2022

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...

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