FDA Approval Insights

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.

Dr Shah discusses the FDA approval of sodium thiosulfate in pediatric patients with solid tumors treated with cisplatin, key efficacy and safety data from the SIOPEL6 and COG ACCL0431 trials, and the importance of multidisciplinary communication when prescribing and administering the agent.

Dr Subbiah discusses the significance of the FDA approval of selpercatinib in RET fusion–positive non–small cell lung cancer, thyroid cancer, and other solid tumors.

Dr Oh discusses the FDA approval of durvalumab plus gemcitabine and cisplatin in biliary tract cancer, the tolerability of the regimen, and the importance of using immunotherapy to treat this disease.

Dr Verstovsek discusses the FDA approval of pemigatinib in myeloid/lymphoid neoplasms with FGFR1 rearrangements, the transformative effects of pemigatinib, and the importance of identifying chromosomal abnormalities in patients with this aggressive disease.

Dr Modi discusses the significance of the FDA approval of trastuzumab deruxtecan in metastatic HER2-low breast cancer, pivotal efficacy and safety data from the DESTINY-Breast04 trial, and how these findings pave the way for further progress across cancer therapy.

Dr Berchuck discusses the effects of treatment intensification with darolutamide in metastatic hormone-sensitive prostate cancer, the significance of the approval of darolutamide plus docetaxel and androgen deprivation therapy, and questions left unanswered by the pivotal ARASENS study.

Dr Ghosh discusses the FDA approval of lisocabtagene maraleucel in large B-cell lymphoma, pivotal efficacy and safety data from the phase 3 TRANSFORM trial (NCT03575351) and the phase 2 TRANSCEND-PILOT-017006 study (NCT03483103), and the effect of the approval on academic and community center practice patterns.

Dr Subbiah highlights the significance of the FDA approval of dabrafenib and trametinib in adult and pediatric patients at least 6 years of age with BRAF V600E–mutant metastatic or unresectable solid tumors and contextualizes the pivotal data for rare tumor types.

Dr Lipson discusses the significance of the regulatory decision for relatlimab and nivolumab, updated data from the RELATIVITY-047 trial, adverse effects clinicians associated with the doublet, and the potential next steps for this therapy in melanoma.

Dr Mesa discusses the data that led to the FDA approval of pacritinib, toxicities clinicians should be aware of when prescribing the JAK inhibitor, and the next steps for pacritinib in the space.

Dr. Choueiri discusses the significance of the FDA approval of pembrolizumab as adjuvant therapy in renal cell carcinoma and key data from the pivotal phase 3 KEYNOTE-564 trial.

Sameek Roychowdhury, MD, PhD, discusses the pivotal phase 2 trial with infigratinib in FGFR-positive cholangiocarcinoma, the safety and efficacy achieved with infigratinib, and the next steps for this agent.

Dr. Shah discusses the FDA approval of brexucabtagene autoleucel in relapsed/refractory B-cell acute lymphoblastic leukemia, key findings from the pivotal ZUMA-3 trial, and next steps with CAR T-cell therapy in the field.

Dr. Patel discusses the role of biomarker testing in lung cancer, the FDA approvals of amivantamab and mobocertinib in EGFR exon 20 insertion–positive NSCLC, and future research directions in this subset of lung cancer.

Dr. Janjigian discusses the FDA approval of nivolumab plus chemotherapy in advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, key findings from the pivotal CheckMate-649 trial, and future directions with immunotherapy in the field.

Dr. Moreau discusses the FDA approval of isatuximab-irfc plus carfilzomib and dexamethasone in relapsed/refractory multiple myeloma, key findings from the pivotal IKEMA trial, and future directions with the combination.

Dr. George and Dr. Hurley discuss the data generated from their study on the correlation between deleterious variants in genes and the development of hereditary breast and ovarian cancers in populations throughout the Caribbean.

Dr. Tagawa discusses the FDA approval of sacituzumab govitecan in urothelial cancer, key efficacy and safety data from the pivotal TROPHY-U-01 trial, and expectations for the confirmatory TROPiCS-04 trial.

Dr. Munshi discusses the significance of the FDA approval of ide-cel in relapsed/refractory multiple myeloma, data from the KarMMa trial, which served as the basis for the approval, and next steps for CAR T-cell therapy in the field.

Dr. Rini discusses unique elements of the TIVO-3 trial, the significance of the FDA approval of tivozanib in advanced RCC, and potential next steps for research with the TKI in the paradigm.

Dr. Landgren discusses the potential of a quadruplet regimen comprised of carfilzomib, lenalidomide, dexamethasone, and daratumumab in the treatment of patients with newly diagnosed multiple myeloma.

Dr. Sezar and Dr. Stratigos discuss the FDA approvals of cemiplimab-rwlc in advanced non–small cell lung cancer and advanced basal cell carcinoma.

Dr. Abramson discusses the significance of the FDA approval of lisocabtagene maraleucel in refractory large B-cell lymphoma and provided insight into the efficacy and safety profiles of the CAR T-cell therapy as reported in the TRANSCEND NHL 001 trial.

Riad Salem, MD, discusses the unique elements of the TheraSphere, the data that supported the regulatory approval, and the anticipated future for the radioembolization technology in hepatocellular carcinoma.