FDA Approval Insights

Dr Galsky discusses the FDA approval of enfortumab vedotin plus pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

Dr Davids discusses the FDA approval of pirtobrutinib for patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma.

Dr Kasper discusses the FDA approval of nirogacestat for patients with progressing desmoid tumors; key efficacy, safety, and quality-of-life outcomes from the pivotal DeFi trial; and findings from an analysis investigating tumor volume and T2 hyperintensity changes with nirogacestat in patients enrolled in DeFi.

Dr Gradishar discusses the FDA approval of capivasertib plus fulvestrant for patients with advanced HR-positive, HER2-negative breast cancer harboring PIK3CA, AKT1, or PTEN alterations.

Drs Hanna and Kandula discuss the significance of the FDA approval of toripalimab in nasopharyngeal carcinoma; pivotal data from the JUPITER-02 and POLARIS-02 trials; and how this regulatory decision increases the importance of multidisciplinary collaboration.

Dr DiNardo discusses the the FDA approval of ivosidenib for patients with relapsed/refractory IDH1-mutant myelodysplastic syndromes, the unique mechanism of action of ivosidenib, and key efficacy and safety findings from the AG120-C-001 trial.

Dr Weber discusses the FDA approval of adjuvant nivolumab for patients with completely resected stage IIB/C melanoma, key efficacy data from the CheckMate76K trial, and potential future directions for PD-1 inhibitor–based combinations in the melanoma treatment paradigm.

Dr Sekeres discusses the FDA approval of quizartinib plus chemotherapy in patients with newly diagnosed, FLT3-ITD–positive AML, key efficacy and safety data from the QuANTUM-First trial, and how this quizartinib regimen addresses an unmet need for older patients in this population.

Dr Carlo-Stella discusses the FDA approval of glofitamab in relapsed/refractory DLBCL, key efficacy and safety findings from the NP30179 trial, and the benefits of glofitamab’s mechanism of action.

Dr Gotlib discusses the significance of the FDA approval of avapritinib in indolent systemic mastocytosis, key findings from the PIONEER trial, and the quality of life benefits that avapritinib provides for patients in this population.

Dr Armstrong discusses the FDA approval of olaparib plus abiraterone in patients with BRCA-mutated mCRPC, key efficacy and safety data from the PROpel trial, and where the field of prostate cancer research may be headed in the future.

Dr Phillips discusses the FDA approval of epcoritamab in patients with relapsed/refractory DLBCL key efficacy and safety findings from the EPCORE NHL-1 trial, and the potential future of bispecific antibodies in this setting.

Dr Horwitz discusses the FDA approval of omidubicel in patients with blood cancers, key efficacy and safety data from the pivotal phase 3 trial, and the benefits omidubicel provides beyond improved neutrophil engraftment.

Dr Friedlander discusses the FDA approval of enfortumab vedotin plus pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma, key efficacy and safety data from the EV-103 trial, and the importance of incorporating this regimen into the frontline setting for this population.

Dr Gilbert discusses the FDA approval of dostarlimab in patients with endometrial cancer, key efficacy data from the GARNET trial, and how this agent bolsters the endometrial cancer treatment paradigm.

Dr Bidard discusses the FDA approval of elacestrant in patients with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, key efficacy and safety data from the EMERALD trial, and the importance of testing for ESR1 mutations in patients with ER-positive, HER2-negative disease.

Dr Tolaney discusses the FDA approval of sacituzumab govitecan in patients with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer; key data from the TROPiCS-02 trial; and how this agent can fulfill unmet needs for this patient population.

Dr Herbst discusses the FDA approval of adjuvant pembrolizumab in non–small cell lung cancer, key efficacy and safety data from the KEYNOTE-091 trial, and future research efforts that may further improve outcomes in this population.

Dr Jakubowiak discusses interim findings from the ATLAS trial of lenalidomide plus carfilzomib and dexamethasone vs lenalidomide maintenance in patients with newly diagnosed multiple myeloma, contextualizes these data within the broader post-transplant landscape, and previews the next steps for this research.

Dr Leslie discusses the FDA approval of pirtobrutinib in patients with MCL previously treated with a BTK inhibitor, key efficacy and safety findings from the BRUIN trial, and potential treatment sequencing strategies in patients with resistance to covalent BTK inhibitors.

Drs Flinn, Lamanna, Brown, and Tam discuss the FDA approval of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma.

Dr Strickler discusses the FDA approval of tucatinib plus trastuzumab in metastatic colorectal cancer, key efficacy and safety findings from the MOUNTAINEER trial, and ongoing research seeking to address remaining unmet needs in this population.

Dr Shore discusses the FDA approval of nadofaragene firadenovec in non–muscle invasive bladder cancer, the benefits of this therapy’s administration method and schedule, and how this agent’s efficacy and safety pave the way for future treatment advances.

Dr Johnson discusses the FDA approval of tremelimumab plus durvalumab and chemotherapy in non–small cell lung cancer, key data from the POSEIDON trial, and the combination’s efficacy and tolerability in various patient populations.

Dr Matulonis discusses the FDA approval of mirvetuximab soravtansine-gynx in folate receptor alpha–positive, platinum-resistant ovarian cancer, key efficacy and safety data from the SORAYA trial, and how further research can continue the momentum behind finding effective ovarian cancer treatments.

Dr Abou-Alfa discusses the FDA approval of durvalumab plus tremelimumab in unresectable hepatocellular carcinoma, the regimen’s unique mechanism of action, and the importance of expanding global access to this combination.

Dr Garfall discusses the FDA approval of teclistamab in relapsed/refractory multiple myeloma, key efficacy and safety data from the MajesTEC-1 trial, and the drug’s unique mechanism of action compared with other anti-myeloma agents.

Dr Goyal discusses the FDA approval of futibatinib in FGFR2-positive cholangiocarcinoma, key safety data from the FOENIX*-CCA2 trial, and the importance of biomarker testing in the cholangiocarcinoma population.