Matthew Stenger
On November 8, 2023, fruquintinib (Fruzaqla) was approved for adults with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy; and—if RAS wild-type and medically appropriate—an anti-EGFR therapy.1 Supporting Effica...
Matthew Stenger
On November 16, 2023, the androgen receptor inhibitor enzalutamide was approved for use in patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.1 Supporting Efficacy Data Approval was based on the EMBARK trial (ClinicalTrials.gov ...
Matthew Stenger
On October 16, 2023, pembrolizumab was approved for use with platinum-containing chemotherapy as neoadjuvant treatment and as single-agent adjuvant treatment in patients with resectable (tumors ≥ 4 cm or node-positive) non–small cell lung cancer (NSCLC).1 Supporting Efficacy Data Approval was base...
Matthew Stenger
On October 11, 2023, the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) was approved for patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA als...
Matthew Stenger
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...
Matthew Stenger
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 ...
Matthew Stenger
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...
Matthew Stenger
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...
Matthew Stenger
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...
Matthew Stenger
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...
Matthew Stenger
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...
Matthew Stenger
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...
Matthew Stenger
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 (...
Matthew Stenger
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...
Matthew Stenger
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...
Matthew Stenger
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 ...
Matthew Stenger
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...
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...
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 ...
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...
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 ...
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 ...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...